University of Miami Department of Medicine, Division of Infectious Diseases – 7 studies
Jackson Medical Towers, 8th Floor East
1500 NW 12th Avenue
Miami, FL 33136
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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ViiV HealthCare/Pfizer - A4001095–1019: A multicenter, randomized, double-blind trial comparing Maraviroc + Darunavir/ Ritonavir vs. Emtricitabine/Tenofovir + Darunavir/Ritonavir for the treatment of antiretroviral naïve HIV-infected patients with CCR5-tropic HIV-1
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P.I.: Dushyantha Jayaweera, M.D.
Contact for further information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
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Waiting for IRB approval
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
Men and women >
18 years of age with CCR5-tropic HIV-1 who have never taken antiretroviral drugs and have a viral load > 1,000 copies/ml and CD4 > 100 cells/mm3
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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Tobira Therapeutics -652: A phase IIb,
multicenter, double blind comparative study to evaluate the efficacy, safety and tolerability of Cenicriviroc in HIV‐1 infected, antiretroviral treatment naïve patients with only CCR5‐tropic virus. Participants will receive either once‐daily 100 mg or 200 mg doses of Cenicriviroc in combination with Truvada or once‐daily Sustiva plus Truvada
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P.I.: Dushyantha Jayaweera, M.D.
Contact for further information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
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Begins 9/1/2011
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
Men and women >
18 years of age with CCR5 tropic virus who have never taken antiretroviral drugs; BMI < 35 kg/m2,
viral load > 5,000 copies/ml and CD4 > 250 cells/mm3
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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University of Minnesota/Insight: Strategic Timing of Anti-Retroviral Treatment (START): A multicenter study of the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
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P.I.: Michael Kolber, M.D.
Contact for further information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
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Begins 9/15/2011
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
Healthy HIV infected men and women > 18 years of age who have never taken antiretroviral drugs or interleukin-2 and have CD4 > 500 cells/mm3
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
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Merck and Co. 35835: A prospective, open-label, single-center pilot study to evaluate the addition of Raltegravir to established suppressive antiretroviral therapy while monitoring changes in markers of immune activation among HIV-1 infected individuals without adequate immune restoration.
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P.I.: Rafael Campo, M.D.
Contact for further information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
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Enrollment open
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
Eligibility:
Men and women > 18 years of age with HIV-1. CD4 count < 350 cells/mm3 at time of enrollment
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
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Viiv HealthCare/Pfizer - A4001098–1021: A multicenter, randomized, blinded, placebo-controlled study to evaluate the safety of Maraviroc in combination with other antretroviral agents in HIV-1 infected subjects co-infected with Hepatitis C and/or Hepatitis B virus.
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P.I.: Dushyantha Jayaweera, M.D.
Contact for further information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
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Begins 9/15/2011
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
Eligibility:
Men and women > 18 years of age who are available for 148 weeks. Undetectable viral load, detectable HCV RNA and/or Hepatitis B positive. Treatment with antiretroviral therapy excluding Ritonavir.
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
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University of Miami Developmental Center for AIDS Research: Recovery of latent reservoirs after treatment for lymphoma in HIV infected patients (Pilot Study).
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P.I.s: Luis Espinoza, M.D./Michael Kolber, M.D.
Contact for further information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
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Enrollment Open
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
Eligibility:
Men and women > 18 years of age. HIV+ lymphoma. On highly active antiretroviral therapy. Non- detectable viral load <50.
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
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Vitamin Study – Double-Blind, randomized, placebo controlled study of Livethesource® daily multi-vitamin (MVI) compared with standard MVI in patients infected with HIV-1
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P.I.: Dushyantha Jayaweera, MD
Contact for further information:
Tom Tanner, R.N.
305/243-5621
TTanner@med.miami.edu
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Waiting UM IRB approval
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
Eligibility:
HIV-1 infected men and women > 18 yrs of age. On stable highly active antiretroviral therapy. CD4 <500 cells/mm3
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University of Miami Department of Pediatrics, Division of Infectious Diseases and Immunology – 1 study
Batchelor Children’s Institute, 1580 NW 10 Avenue Suite 287
Miami, Fl 33136
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clinical Trial
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International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) – PROMISE Study: The study will determine if women who receive highly active antiretroviral therapy (HAART) during pregnancy and continue their regimen after delivery will have less morbidity and mortality than those who only receive HAART during pregnancy and stop after delivery. The study also will evaluate the likelihood of developing resistance to HIV meds in women who stop compared with those who continue HAART after delivery. The study will supply antiretroviral medications.
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P.I.: Gwendolyn Scott, M.D.
Contact for further information:
Patricia Bryan, R.N.
305/243-4447
PBryan@med.miami.edu
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Enrollment open
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MEDICATION TRIALS:
Eligibility:
Pregnant women who have only taken antiretroviral therapy in pregnancy and have CD4 cells of 400 or higher.
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University of Miami AIDS HIV Women’s Program – 2 studies
(Dept. Obstetrics and Gynecology)
Clinical Research Building
1120 NW 14th Street, 7th Floor
Miami, FL 33136
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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Tibotec. A single arm open label study to assess the pharmacokinetics of Rilpivirine in HIV-1 pregnant women.
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P.I.: Salih Yasin, M.D.
Contact for further information:
Yvette Rivero
305/243-2169
YRivero@med.miami.edu
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Enrollment open
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
Women ≥ 18 years of age who have never taken antiretroviral drugs and are between 18-24 weeks pregnant.
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
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Tibotec. A single arm open label study to assess the pharmacokinetics of Darunavir/Ritonavir and/or Etravirine in HIV-1 pregnant women
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P.I.: Salih Yasin, M.D.
Contact for further information:
Yvette Rivero
305/243-2169
YRivero@med.miami.edu
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Enrollment open
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
Eligibility:
Women ≥ 18 years of age, with a history of taking antiretroviral drugs, who are between 18-24 weeks pregnant.
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Wohlfeiler, Piperato & Associates, LLC – 6 studies
1613 Alton Road
Miami Beach, FL 33139
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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Sangamo Biosciences
(selected as site – details pending)
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P.I.: Michael Wohlfeiler, M.D.
Contact for further information:
Daniel Guzman, CRC 305/538-1400 ext: 222
danielguzmanwpa@aol.com
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Selected as a site – waiting for contract approval
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
Men and women >
18 years of age never taken antiretroviral drugs and have a viral load > 2,500 copies/ml and CD4 > 500 cells/mm3
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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Sangamo Biosciences
(selected as site – details pending)
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P.I.: Michael Wohlfeiler, M.D.
Contact for further information:
Daniel Guzman, CRC 305/538-1400 ext: 222
danielguzmanwpa@aol.com
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Selected as a site – waiting for contract approval
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
Men and women >
18 years of age never taken antiretroviral drugs and have a viral load > 2,500 copies/ml and CD4 > 500 cells/mm3
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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Gilead Sciences – GS-0118: A phase III trial to characterize the effect of Cobicistat-based regimens in patients with mild to moderate renal impairment.
NCT01363011
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P.I.: Michael Wohlfeiler, M.D.
Contact for further information:
Daniel Guzman, CRC 305/538-1400 ext: 222
danielguzmanwpa@aol.com
Contact: Andrew Plummer (650) 522-6173 Andrew.Plummer@gilead.com
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Enrollment Open
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
HIV infected men and women > 18 years of age who have never taken antiretroviral drugs, have a viral load > 1,000 copies, and have mild to moderate renal impairment.
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
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ViiV Healthcare –111762: A multicenter, randomized, double-blind study of the safety and efficacy of GSK 1349572 (50 mg. once daily) versus Raltegravir (400 mg. twice daily) added to an optimized background regimen.
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P.I.: Michael Wohlfeiler, M.D.
Contact for further information:
Daniel Guzman, CRC 305/538-1400 ext: 222
danielguzmanwpa@aol.com
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Enrollment Open
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
Eligibility:
HIV-infected men and women >
18 years of age who are antiretroviral experienced and are integrase inhibitor naïve.
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
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ViiV Healthcare – ASSURE: A randomized phase 4 switch study designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC) without RTV in virologically suppressed, HIV-1 infected subjects.
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P.I.: Michael Wohlfeiler, M.D.
Contact for further information:
Daniel Guzman, CRC 305/538-1400 ext: 222
danielguzmanwpa@aol.com
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Enrollment Open
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MEDICATION TRIALS: Treatment experienced (history of Current or Past Use of Antiretroviral Therapy)
Eligibility:
Men and women >
18 years of age. 1) TDF/3TC + ATV/r (300/100 mg) must be patient’s initial antiretroviral regimen or the first or second switch regimen, 2) virologically suppressed on TDF/FTC + ATV/r, 3) must be HLA-B*5701 negative.
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Trials for HIV-Associated Conditions
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Salix Pharmaceuticals – CFHD3092: This study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (HIV+) subjects with diarrhea.
NCT01374490
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P.I.: Michael Wohlfeiler, M.D.
Contact for further information:
Daniel Guzman, CRC 305/538-1400 ext: 222
danielguzmanwpa@aol.com
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Enrollment open
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Trials for HIV-Associated Conditions
Eligibility:
HIV-infected adults who have been on antiretroviral therapy for at least 4 weeks prior to screening with self-reported presence of diarrhea
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Miami Beach Community Health Center, Inc. – 1 study
710 Alton Road
Miami Beach, FL 33139
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Trials for HIV-Associated Conditions
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KOWA Research Institute – NK-104-4.05US: A study comparing Pitavastatin (4 mg.) vs. Pravastatin (40 mg.) in HIV-infected subjects with dyslipidemia.
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P.I.: Mark Keller, M.D.
Contact for further information:
Alice Lopez
305/866-8915
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Enrollment open
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Trials for HIV-Associated Conditions
E ligibility:
HIV-infected men and women, ages 18-70, who have taken antiretroviral drugs for at least 6 months. LDL > 130 mg. and < 220 mg. and triglyceride levels < 400.
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University of Miami, AIDS Clinical Research Unit – 4 studies
Elliot Building, Room 2016
1800 NW 10th Avenue, Miami FL 33136
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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AIDS Clinical Trials Group – 5303: A phase-IIIb trial to evaluate bone, immunologic, virologic and neuro-cognitive effects of Maraviroc-containing antiretroviral therapy regimen in patients infected with CCR5 tropic HIV-1
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P.I.: Margaret Fischl, M.D.
Contacts for further information:
Juan Casuso
305/243-3838
jcasuso@med.miami.edu
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Expect to begin enrolling
9/2011
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
Men and women >
18 years of age with documented CCR5 only virus. Excludes those who are Hep-B+, pregnant, weigh > 300 lbs., have bone fractures related to osteoporosis or bone fragility, or active drug or alcohol abuse.
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
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ViiV Healthcare/Pfizer UK-427: A comparative study of Maraviroc/ Darunavir/Ritonavir vs. Truvada/Darunavir/
Ritonavir in ARV-naïve individuals with CCR5 tropic HIV-1 infection
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P.I.: Margaret Fischl, M.D.
Contacts for further information:
Juan Casuso
305/243-3838
jcasuso@med.miami.edu
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Enrollment Open
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MEDICATION TRIALS: Treatment Naïve – No PAST USE OF ANTIRETROVIRAL THERAPY
Eligibility:
Men and women > 18 years of age with CCR5 tropic HIV-1 infection. Excludes pregnant women and those with acute hepatitis or pancreatitis, renal insufficiency, HepB+ or CXCR4 HIV-virus.
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Trials for HIV-Associated Conditions
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AIDS Clinical Trials Group – A-5279: A phase-III trial of short course Rifapentine/ Isoniazid for the prevention of active tuberculosis (TB) in HIV-infected individuals with latent TB infection.
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P.I.: Margaret Fischl, M.D.
Contacts for further information:
Juan Casuso
305/243-3838
jcasuso@med.miami.edu
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Expected to begin 9/2011
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Trials for HIV-Associated Conditions
Eligibility:
HIV-1 infection, positive TB test prior to study entry. Excludes those with current pregnancy, active TB within 2 years of study entry, on P.I.-based or Raltegravir –regimen; liver cirrhosis, acute hepatitis.
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Trials for HIV-Associated Conditions
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AIDS Clinical Trials Group - A5247: A phase II clinical trial to evaluate the safety, tolerability and immune response of ZOSTAVAX® (Zoster Vaccine Live) in HIV-1-infected adults on combination ART.
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P.I.: Margaret Fischl, M.D.
Contacts for further information:
Juan Casuso
305/243-3838
jcasuso@med.miami.edu
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Enrollment open
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Trials for HIV-Associated Conditions
Eligibility:
Men and women ≥ 18 yrs of age with a history of shingles (herpes zoster in the past one year) who are taking combination ARV therapy and have a viral load < 50 copies/ml and CD4 cell count ≥ 200
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UNIVERSITY OF MIAMI – 28 Studies
Presenter: Savita Pahwa, M.D.
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clinical Trial
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Adolescent Medicine Trials Network for HIV/AIDS Interventions, aka ATN (longstanding collaborative NIH research consortium continually funded here since 2001 following previous 1994-2001 award for REACH Protocol)
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Lawrence B Friedman, MD (PI)
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Pediatrics/Division of Adolescent Medicine
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Youth 13-24 y/o with HIV infection or high-risk attributes (numerous therapeutic, behavioral, and community studies that continuously are introduced, implemented and completed). No drug or treatment protocols are open presently.
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clinical Trial
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group
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Charles Mitchell, Gwendolyn Scott
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Microbiology and Immunology, Pediatrics
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U01
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clinical Trial
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Miami HIV/AIDS Clinical Therapeutic and Vaccine Trial Unit
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Margaret Fischl
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Medicine
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NIAID
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clinical Trial
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Atherosclerotic Risk and Response to Exercise Intervention in HIV+ Children
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Tracie L. Miller
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Pediatrics
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NHLBI
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clinical Trial
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DIETARY INTAKES AND PATTERNS, BIOMARKERS, AND MATERNAL AND INFANT OUTCOMES IN HIV
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Tracie L. Miller
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Pediatrics
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NICHD
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clinical Trial
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University of Miami Pediatric Perinatal HIV/AIDS Clinical Trails Unit
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Gwendolyn B. Scott
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Pediatrics
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NIAID
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clinical Trial
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Florida Node Alliance of the Drug Abuse Clinic Trials Network
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Jose Szapocznik
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Epidemiology & Pub. Health Med.
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NIDA
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clinical Trial
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AIDS Malignancy Consortium University of Miami Core Site
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Juan Carlos Ramos
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Therapeutics Research
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NCI
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clinical Trial
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NIAID IRAC: combination influenza treatment in high risk and low risk patients with acute influenza
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Margaret Fischl
Hector Bolivar
Jose Castro
Michelle Morris
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Therapeutics Research
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NIAID
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clinical Trial
Basic Science/Virology
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Effect of Raltegravir on immune activation, immune reconstitution and gut microbial translocation in patients with chronic HIV infection
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Rafael Campo
Savita Pahwa
Mario Stevenson
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Novel therapeutics and pathogenesis
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Merck
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clinical Trial
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P1077HS:HAART Standard Version of the PROMISE Study: Promoting Maternal and Infant Survival Everywhere
P1083: A Phase II/III Trial of Lopinavir/Ritonavir Dosed According to The WHO Pediatric Weight band Dosing Guidelines
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IMPAACT Studies
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The purpose of this study is to see if pregnant women receiving highly active antiretroviral treatment (HAART) to prevent mother-to-child transmission of HIV will be healthier if, after delivery, they continue or stop HAART.
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Clinical Trial
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GS-US-236-0102 - A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Vs Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults.
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Rafael Campo
On-Going
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Medicine
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Treatment comparison
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Clinical Trial
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GS-US-216-0114: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naїve Adults
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Rafael Campo
On-Going
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Medicine
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Naive
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Clinical Trial
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GS-US-264-0106-A Phase 3 Randomized Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine /Rilpivirine/ Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV 1 Infected
Patients
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Rafael Campo
New-Enrolling soon
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Medicine
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Clinical Efficacy
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Clinical Trial
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A4001067 - An International, Multi-center, Prospective Observational Study of the safety of Maraviroc used with Optimized Background Therapy in Treatment-Experienced HIV-1 Infected Patients.
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Jose Castro
On-Going
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Medicine
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Clinical Efficacy
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Clinical Trial
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MIDAS - Maraviroc Plus Darunavir/ritonavir Study for treatment-Naïve Patients Infected with R5 tropic HIV-1 based on Enhanced Sensitivity Trofile
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Jose Castro
On-Going
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Medicine
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Clinical Efficacy
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Clinical Trial
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A4001098 – 1021 - A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY OF MARAVIROC IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS IN HIV-1-INFECTED SUBJECTS CO-INFECTED WITH HEPATITIS C AND/OR HEPATITIS B VIRUS
NCT01327547
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Dushyantha Jayaweera
Contact: Pfizer CT.gov Call Center 1-800-718-1021
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Medicine
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Clinical Efficacy
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Clinical Trial
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A0081244 – 1029 - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER TRIAL OF PREGABALIN VERSUS PLACEBO IN THE TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH HIV NEUROPATHY (PREGABALIN A0081244)
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Jose Castro
Enrolling
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Medicine
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Clinical Efficacy
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Clinical Trial
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A0081251 – 1029 - AN OPEN-LABEL, EXTENSION SAFETY TRIAL OF PREGABALIN IN SUBJECTS WITH NEUROPATHIC PAIN ASSOCIATED WITH HIV NEUROPATHY.
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Jose Castro
Enrolling
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Medicine
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Clinical Efficacy
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Clinical Trial
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TMC278-TiDP6-C215: A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects
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Jose Castro
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Medicine
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Clinical Efficacy
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Clinical Trial
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TMC-278-TiDP6-C222 - An open-label trial with TMC278 25 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected subjects, who participated in TMC278 clinical trials.
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Jose Castro
New-Roll-over for C215
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Medicine
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Clinical Efficacy
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Clinical Trial
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A4001078 – 1045 - Pilot Study of Novel Combination of Maraviroc + Atazanavir/ Ritonavir Vs. Atazanavir/ Ritonavir + Emtricitabine/ Tenofovir For The Treatment Of Treatment Naïve HIV-Infected Patients With R5 HIV-1
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Dushyantha Jayaweera
On-Going
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Medicine
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Clinical Efficacy
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Clinical Trial
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A4001095 – 1019 - A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE TRIAL OF MARAVIROC + DARUNAVIR/RITONAVIR VERSUS EMTRICITABINE/TENOFOVIR + DARUNAVIR/RITONAVIR FOR THE TREATMENT OF ANTIRETROVIRAL-NAÏVE HIV-INFECTED PATIENTS WITH CCR5-TROPIC HIV-1
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Dushyantha Jayaweera
New – On-Hold Per Sponsor
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Medicine
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Clinical Efficacy
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Clinical Trial
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Protocol VX08-950-110: A Phase 2A, 2-Part, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study of Telaprevir in Combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects who Have Chronic HCV-1/HIV-1 Co-Infection and are Treatment-Naïve for Hepatitis C
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Dushyantha Jayaweera
On-Going
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Medicine
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Clinical Efficacy
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Clinical Trial
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A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR 652) or Once-Daily EFV, Each With Open-Label FTC/TDF in HIV 1-Infected, Antiretroviral Treatment-Naïve, Adult Patients with Only CCR5-Tropic Virus
NCT01338883(?)
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Contact: Tom Tanner 786-413-7546 ttanner@med.miami.edu
Principal Investigator: Dushyantha Jayaweera, MD
Contact: Anne Oesterbo, BSN, RN (910) 228-5076 anne.oesterbo@quintiles.com
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Medicine
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Clinical Efficacy
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Clinical Trial
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Recovery of Latent Reservoirs After Treatment for Lymphoma in HIV Infected Patients: A Pilot Study
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Luis Espinoza/Michael Kolber
Enrolling
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Medicine
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Viral reservoirs
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Clinical Trial
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Strategic Timing of Anti-Retroviral Treatment (START) - A Multicenter Study of the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
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Michael Kolber
New – Enrolling soon
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Medicine
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INSIGHT –multicenter
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Clinical Trial
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Retaining HIV Positive Patients in Medical Care: Test for Intervention Strategies for HIV Clinics (Phase II)
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Allan Rodriguez
On-Going
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Medicine
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CDC retention in care
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UNIVERSITY OF SOUTH FLORIDA – 25 Studies
Presenter: John W. Sleasman, M.D.
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Clinical Trial
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Pfizer- A40001031. Phase I/II trial on the use of maraviroc in HIV infected children and adolescents
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Carina Rodriguez, MD (site PI), John Sleasman, MD, Patricia Emmanuel, MD, Jorge Lujan, MD, Alicia Marion, ARNP, Kenneth Kavanagh, ARNP (Co-Investigators)
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Pediatric Infectious Diseases
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CCR5 inhibitor for HIV treatment in HIV infected children and adolescents
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Clinical Trial
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NO1-HD-8-0001NIH/NICHD Pediatric AIDS Clinical Trials Group (IMPAACT).
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Patricia Emmanuel, MD (PI), Carina Rodriguez, MD, John Sleasman, MD Jorge Lujan, MD, Alicia Marion, ARNP, Kenneth Kavanagh, ARNP (Co-Investigators)
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Pediatric Infectious Diseases
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Multicenter clinical trial related to therapy, HIV related complications, vaccines, and perinatal transmission.
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Clinical Trial
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U01 HD040497-06 NIH, Adolescent Trials Network
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Patricia Emmanuel, MD (PI), Diane Straub, MD, John Sleasman, MD, Carina Rodriguez, MD, Jorge Lujan, MD, Alicia Marion, ARNP, Kenneth Kavanagh, ARNP (Co-Investigators)
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Pediatric Infectious Diseases
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ATN is a national, multicenter research network, to conduct research to explore behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected and HIV at-risk adolescents, age 12 through 24
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Clinical Trial
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Changes in the B cell repertoire following vaccination with novel H1N1 inactivated influenza vaccine in immune deficient adolescents and young adults chronically infected with HIV
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Carina Rodriguez, MD (PI), John Sleasman, MD, Li Yin, PhD, Maureen Goodenow, PhD
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Pediatric Infectious Diseases, Allergy and Immunology (USF) and Pathology (UF)
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Immunologic responses to H1N1 inactivated influenza vaccine in HIV-infected adolescents and young adults
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Clinical Trial
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Treatment De-intensification and Residual HIV-1 in Youth. (ATN 081)
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John Sleasman
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Allergy and Immunology, USF
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Effects of early treatment followed by treatment deintensification. Sponsor: NICHD
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Clinical Trial
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Preservation & Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/ritonavir (ATN 061)
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John Sleasman
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Allergy and Immunology, USF
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Early treatment of HIV during deintensification to ATV/r.
Sponsor: NICHD
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Clinical Trial
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Longitudinal changes in cardiovascular risk markers among adolescents newly infected with HIV (ATN 083)
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John Sleasman
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Allergy and Immunology, USF
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Cardiovascular risks in HIV-infected adolescents.
Sponsor: NICHD
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Clinical Trial
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Assessment of inflammatory Markets Associated with Neurocognitive impairment in HIV-infected Adolescents (ATN 101)
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John Sleasman
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Allergy and Immunology, USF
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Neurocognitive impairment in HIV.
Sponsor: NICHD
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Clinical Trial
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A randomized placebo controlled trial of probiotics to lower microbial translocation & immune activation in HIV-infected adolescents
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John Sleasman
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Allergy and Immunology, USF
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LPS levels and immunity preservation.
Sponsor: NICHD
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Clinical Trial
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ATN 081/083 Processing Contracts – ATN Coordinating Center
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John Sleasman (PI)
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Pediatrics
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Clinical Trial
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Leadership Group for Adolescent Medicine Trials Network
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John Sleasman (PI)
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Pediatrics
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Clinical Trial
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Protocol #Hizentra Transition Study
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John Sleasman (PI)
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Pediatrics
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Clinical Trial
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Impact of HIV-1 Genotype on Therapy Response in Children
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John Sleasman (PI)
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Pediatrics
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Clinical Trial
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Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Crofelemer 125 mg, 250 mg and 500 mg Orally Twice Daily for the Treatment of HIV-Associated Diarrhea (ADVENT Trial)
NCT01374490(?)
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Beata Casanas (PI)
Contact: Alyson Lineberry 919-862-1000
alyson.lineberry@salix.com
Contact: Jeff Cohn
919-862-1000
jeff.cohn@salix.com
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Internal Medicine
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Complications, therapy GI: diarrhea
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Clinical Trial
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A Phase III, randomized, double-blind trial of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects
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Beata Casanas (PI)
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Internal Medicine
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primary therapy
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Clinical Trial
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A Phase llb randomized, partially blinded, dose-finding trial of TMC278 in antiretroviral naïve HIV-1 infected subjects
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Beata Casanas (PI)
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Internal Medicine
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primary therapy
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Clinical Trial
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An Open-label, Multicenter, Multiple-dose Pharmacokinetic and 48-week Safety and Efficacy Trial of Maraviroc in Combination with Optimized Background Therapy for the Treatment of Antiretroviral-Experienced CCR5-Tropic HIV-1 Infected Children 2-18 Years
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Carina Rodriguez (PI)
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Pediatrics
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Primary therapy
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Clinical Trial
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A Phase 1B Study of the Safety and Pharmacokinetics of Ritonavir-Boosted Elvitegravir (EVG/r) Plus a Background Regimen (BR) in HIV-1 Infected, Antiretroviral Treatment-Experienced Adolescents
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Patricia Emmanuel (PI)
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Pediatrics
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pharmacokenetics, HIV therapy
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Clinical Trial
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group
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Patricia Emmanuel (PI)
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Pediatrics
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Prevention of maternal to child transmission, pediatric treatment studies
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Clinical Trial
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Adolescent Medicine Trials Network II
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Patricia Emmanuel (PI)
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Pediatrics
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Multicenter trials group, prevention and treatment studies in HIV at risk and infected youth
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Clinical Trial
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Efficacy and Safety of Vicriviroc in HIV-Infected Treatment-Naïve Subjects
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Chararut Somboonwit (PI)
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primary therapy
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Clinical Trial
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A Phase II randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability and safety of TMC125 as part of an ART including TMC114/RTV and an investigator-selected OBR in HIV-1 infected subjects
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Todd Wills (PI)
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Internal Medicine
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HIV therapy
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Clinical Trial
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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-3950-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment Naive Adults
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Todd Wills (PI)
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Internal Medicine
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HIV therapy
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Clinical Trial
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A Phase 3, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9173/r) Administered in Combination with Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects
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Todd Wills (PI)
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Internal Medicine
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HIV therapy
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Clinical Trial
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A Phase 3, Randomizes, Double-Blind, Study to Evaluate the Safety and Efficacy of Elivitegravir/Emtricitabine/Tenofovir disoproxil Fumarate-GS-9350 Versus Efavirenz/Emtriciitabane/ Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
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Todd Wills (PI)
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Internal Medicine
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primary therapy
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ORANGE COUNTY HEALTH DEPARTMENT – 2 Studies
Presenter: Gerald Horton, Jr. M.D.
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Clinical Trial
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INSIGHT PROTOCOL001- Strategic Timing of AntiRetroviral Treatment (START); Version2. (Not Yet Started)
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Dr. Gerald Horton (PI), Dr. Richard Solero and Dr. Nila Desai (CoPIs)
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HugMe Immunology Clinic
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HIV Adults Sponsor: NIH, University of Minnesota, Washington DC International Coordinating Center (ICC)
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Clinical Trial
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Protocol AI424403: An open-label, randomized study evaluating a switch from a regimen of two nucleoside reverse transcriptase inhibitors plus any third agent to either a regimen of Atazanavir/Ritonavir once daily & Raltegravir twice daily or to a regimen of Atazanavir/Ritonavir once daily & Tenofovir/Emtricitabine once daily in virologically suppressed HIV-1 infected subjects with safety and/or tolerability issues on their present treatment regimen (Not Yet Started)
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Dr. Nila Desai (PI) and Dr. Richard Solero/ Dr. Lynn Hopkins (CoPIs)
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Central Immunology Clinic
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HIV Adults
Sponsor: Bristol-Myers Squibb
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UNIVERSITY OF FLORIDA
Presenter: Maureen Goodenow, Ph.D.
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Clinical Trial
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Pharmacotherapy to reduce hazardous drinking in HIV-Infected women
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Robert L. Cook (PI)
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Epidemiology
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Alcohol
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FLORIDA INTERNATIONAL UNIVERSITY – 3 Studies
Presenter: Mario De La Rosa, Ph.D.
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Clinical Trial
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Zinc Therapy in Zinc Deficient HIV+ Drug Users
Supplements to this project:
Effect of Zinc Supplementation on Cytokine Modulation, HHIV-HCV Coinfection and Antioxidant Status
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Marianna Baum, PI, and Adriana Campa, Co-PI
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Robert Stempel College of Public Health and Social Work (Recently Completed Studies)
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A seven-year clinical trial that compared the effects of zinc /placebo supplementation on HIV disease progression, and extended its research objectives by funded supplemental research into the effects of zinc in modulating cytokine responses and decreasing oxidative stress in HIV/HCV co-infection Funded by NIDA
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Clinical Trial
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"HIV-Risk Reduction for Teens in Alcohol Treatment.”
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Jonathan Tubman (PI)
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Robert Stempel College of Public Health and Social Work (Recently Completed Studies)
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Randomized, clinical trial to evaluate the efficacy of clinic-based HIV-risk reduction intervention for multi-ethnic youth undergoing outpatient treatment for alcohol and other drug abuse problems; Funded by NIAAA
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Clinical Trial
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Micronutrient Therapy in HIV+ Adults in Botswana.
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Marianna Baum (PI) and Adriana Campa, Co-PI
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Robert Stempel College of Public Health and Social Work (Recently Completed Studies)
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A seven-year clinical trial of micronutrient rplementation in collaboration with the Harvard School of Public Health and the Botswana-Harvard Partnership. Funded by NIDA
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