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Clinical Trial
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Efficacy of an Accelerated, High-Dose, Hepatitis B Immunization Series in HIV-Infected Patients
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Levonne Mitchell-Samon, MD (PI) Sub-Investigators: Michael Sands, MD, MPH &TM Nilmarie Guzman, MD Christina L. Bailey, MD
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Infectious Diseases Division and Department of Health Boulevard Comprehensive Care Center
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Hepatitis B Vaccination scheduling and dosing in HIV-Infected Patients
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Clinical Trial
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Strategic Timing of AntiRetroviral Treatment (START)
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Michael Sands, MD, MPH & TM Sub-Investigators: Nilmarie Guzman, MD Christina L. Bailey, MD Mobeen Rathore, MD
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Infectious Diseases Division
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HIV and initiation of ART
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Clinical Trial
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A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (Isentress™, MK-0518) in HIV-1 Infected Children and Adolescents IMPAACT P1066
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Mobeen Rathore, MD
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Pediatrics
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Keywords: HIV, Raltegravir in HIV-infected children, teens
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Clinical Trial
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A Phase II Safety and Immunogenicity Study of Quadrivalent Human Papilloma Virus [TYPES 6, 11, 16, 18] L1 Virus-Like Particle [VLP] Vaccine (GARDASIL®) in HIV-Infected Children (greater or equal to) 7 to < 12 Years of Age P1047 Ver. 1.0
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Mobeen Rathore, MD
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Pediatrics
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HIV, HPV Vaccine
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Clinical Trial
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A5240: A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females
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Mobeen Rathore, MD
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Pediatrics
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HIV, HPV Vaccine
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Clinical Trial
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A5257: A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers (The ARDENT Study: Atazanavir, Raltegravir, or Darunavir with Emtricitabine- Tenofovir for Naïve Treatment)
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Mobeen Rathore, MD
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Pediatrics
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HIV infected women; HIV medication study
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Clinical Trial
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An Open-label, Multicenter, Multiple-dose Pharmacokinetic & 48-week Safety & 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 of Age (A4001031)
NCT00791700
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Mobeen Rathore, MD
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Pediatrics
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HIV, maraviroc
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Clinical Trial
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IMPAACT P1065: Phase I/II, Study of Safety and Immunogenicity of Quadrivalent Meningococcal Conjugate Vaccine (MCV-4) In HIV-Infected Children and Youth
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Mobeen Rathore, MD
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Pediatrics
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HIV, meningococcal conjugate vaccine, children, youth
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Clinical Trial
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IMPAACT P1086 A Phase II Study to Assess the Safety & Immunogenicity of an Inactivated A(H1N1) 2009 Monovalent Vaccine in HIV-1 Infected Pregnant Women
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Mobeen Rathore, MD
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Pediatrics
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HIV-infected pregnant women, H1N1 influenza vaccine
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Clinical Trial
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IMPAACT P1088: A Phase II Study to Assess the Safety & Immunogenicity of an Inactivated Influenza A (H1N1) 2009 Monovalent Vaccine in HIV-1 Perinatally Infected Children & Youth
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Mobeen Rathore, MD
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Pediatrics
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HIV and H1N1
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Clinical Trial
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Phase III, Randomized Trial of the Safety & Efficacy of Three Neonatal Antiretroviral Regimens for the Prevention of Intrapartum HIV-1 Transmission (NICHD/HPTN 040/P1043)
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Mobeen Rathore, MD
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Pediatrics
|
|
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Clinical Trial
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A5257: A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1-Infected Volunteers (The ARDENT Study: Atazanavir, Raltegravir, or Darunavir with Emtricitabine/Tenofovir for Naïve Treatment)
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Mobeen Rathore, MD
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Pediatrics
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HIV infected women; HIV medication study
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Clinical Trial
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An International, Multicenter, Prospective Observational Study of the Safety of Maraviroc used with Optimized Background Therapy in Treatment-Experienced HIV-1 Infected Patients (POEM)
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Nilmarie Guzman, MD (PI) Sub-Investigators: Michael Sands, MD, MPH & TM,
Christina L. Bailey, MD, Levonne Mitchell-Samon, MD
Catherine Rogers, PA-C
Ne’Tosha Dopson, PA-C
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Infectious Diseases Division
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HIV-1; maraviroc safety in long-term use
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Clinical Trial
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IMPACCT 1077 HS: HAART Standard Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere), Version 1.0
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Mobeen Rathore, MD
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Pediatrics
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HIV, post partum
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Clinical Trial
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Pharmacotherapy for Hazardous Drinking in HIV Infected Women: Randomized Trial
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Robert Cook, MD, MPH and Mobeen Rathore, MD
Contact: Robert L Cook, MD, MPH 352-273-5869 cookrl@ufl.edu
Contact: Manju Karki, MPH 352-273-9562 karkim@ufl.edu
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Pediatrics
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Hazardous Drinking Behavior, HIV, alcohol, naltrexone
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Broward Children’s Diagnostic & Treatment Center - 12 Studies
Presented by Ana Puga, M.D.
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Clinical Trial
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ATN 061: Preservation and Expansion of T-cell Subsets Following Highly Active Antiretroviral Therapy (HAART) De-intensification to Atazanavir/ritonavir (ATV/r) in Adolescents and Young Adults with CD4 + T Cells > 350 and HIV RNA < 100,000 Initiating HAART (on-going)
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Ana Puga, MD
Barbara Moscicki
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CFAP Research
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Antiretroviral Therapy (ART) in adolescents
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Clinical Trial
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ATN 064: Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6,-11,-16,-18 Vaccine in HIV-Infected Young Women (closed)
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Ana Puga, MD
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CFAP Research
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Human Papilloma Virus (HPV) vaccine in adolescents
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Clinical Trial
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Campbell Study: HPV Infections and Associated Morbidity in Children and Adolescents Perinatally Infected with HIV
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Ana Puga, MD
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CFAP Research
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HPV in Perinatally Infected Children/Youth
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Clinical Trial
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IMPAACT 1077HS: HAART Standard Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) (recruiting)
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Ana Puga, MD
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CFAP Research
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HIV and Pregnancy
Postpartum Antiretroviral Treatment Strategy
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Clinical Trial
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IMPAACT 1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug combinations in Children, Adolescents and Young Adults (recruiting)
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Ana Puga, MD
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CFAP Research
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Pharmacokinetics of Newer Agents in Children/Youth.
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Clinical Trial
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IMPAACT 1066: A Phase I/II, Multicenter, Open-Label, Noncomparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Raltegravir (MK-0518) in HIV-1 Infected Children and Adolescents (recruiting)
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Ana Puga, MD
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CFAP Research
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Raltegravir in Children
Pharmacokinetics
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Clinical Trial
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IMPAACT A5240: A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1 Infected Females (recruiting)
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Ana Puga, MD
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CFAP Research
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HPV in Adult HIV positive females
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Clinical Trial
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IMPAACT A5241: The Optimized Treatment that Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for HIV-1 Infected Treatment-Experience Subjects Using the cPss to Select an Effective Regimen (recruiting)
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Ana Puga, MD
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CFAP Research
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Salvage Antiretroviral Therapy (ART)
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Clinical Trial
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IMPAACT A5257: A Phase III Comparative Study of Three Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)-Sparing Antiretroviral Regimens for Treatment-Naïve HIV-1 Infected Volunteers (recruiting)
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Ana Puga, MD
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CFAP Research
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Antiretroviral Therapy Strategy
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Clinical Trial
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IMPAACT P1063: Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of Increased LDL Cholesterol In HIV-Infected Children, Adolescents, and Young Adults (recruiting)
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Ana Puga, MD
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CFAP Research
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Pharmacokinetics
Cholesterol treatment for children/youth
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Clinical Trial
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IMPAACT P1093: A Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572, A Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents. 2/9/2011 - Present (recruiting)
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Ana Puga, MD
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CFAP Research
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Novel Intergrase in children
Pharmacokinetics
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Clinical Trial
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IMPAACT P1096: A Companion Protocol to CIR Protocol Number: CIR255
Phase 1 Study to Determine the Safety, Infectivity, Immunogenicity and Tolerability of 2 Doses of Live Attenuated Recombinant Cold-passaged (cp) 45 Human Parainfluenza Type 3 Virus Vaccine, rHPIV3cp45, Lot PIV3#102A, Delivered as Nose Drops to HPIV3-Seronegative Infants and Children 6 to 36 Months of Age, at a 6 Month Interval (recruiting)
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Ana Puga, MD
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CFAP Research
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Human Parainfluenza Vaccine in HIV negative Children
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ClinicalTrials.gov Website Studies – 39 Additional Studies
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Clinical Trial
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Sleep Quality and Presence of Sleep Disordered Breathing In An Inner City African American HIV Infected Population Aged 50 Years and Older
NCT00692965
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Supriya Mannepalli, MD, Akram Khan, MD
Contact: Katherine Rogers, BSN904-253-1261
katherine_rogers@doh.state.fl.us
Contact: Supriya Mannepalli, MD904-253-1040
Supriya_mannepalli@doh.state.fl.us
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University of Florida
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Clinical Trial
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A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1
NCT 00823979
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Study Director: Pfizer CT.gov Call CeFnter
1-800-718-1021
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Percentage of subjects with HIV-1 RNA <50 copies/mL at 24 weeks.; The percentage of subjects with HIV-1 RNA <50 copies/mL and <400 copies/mL at various time points; The change from baseline in log10 transformed HIV 1 RNA levels; Assessment of Genotypic and phenotypic resistance at various time points; The time-averaged difference (TAD) in log10 transformed HIV 1 RNA levels at various time points.; The percentage of subjects with virologic response at different time points.; Change from baseline in CD4+ cell counts (absolute and percentage).; Safety and tolerability as measured by spontaneous adverse event reports, serious adverse events and safety laboratory tests.; Pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analyses (to be reported separately). Sponsor: Pfizer
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Clinical Trial
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A Study to Assess the Pharmacokinetics (Blood Levels) of TMC114 (Darunavir) Taken With TMC114r (Ritonavir), and TMC125 (Etravirine) in HIV-1 Infected Pregnant Women
NCT00855335
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Tibotec, Inc. Clinical Trial
Recruiting: Daytona Beach, Miami, Pensacola, Port St. Lucie, West Palm Beach, Florida
JNJ.CT@sylogent.com
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To assess the influence of pregnancy on the pharmacokinetics of darunavir/ritonavir (darunavir/r) and/or etravirine during the second and third trimesters of gestation, as well as postpartum; Changes in anti-viral activity and safety and tolerability of darunavir/r and/or etravirine-based antiretroviral regimens during gestation and postpartum; compare darunavir/r and/or etravirine concentrations between serum and cord blood; pregnancy outcome
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Clinical Trial
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Optimizing Treatment for Treatment-Experienced, HIV-infected People
NCT00537394
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National Institute of Allergy and Infectious Diseases
AIDS Clinical Trials Group
Karen T. Tashima, MD,
Brown University;
Richard H. Haubrich, MD, Division of Infectious Diseases, UCSD Antiviral Research Center
This study is ongoing, but not recruiting participants.
Responsible Party:
Rona Siskind, DAIDS
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Time to regimen failure; Toxicity, as defined as time to first Grade 3 or higher (and one grade higher than baseline) signs/symptom or laboratory abnormality; Tolerability, as defined as time to first dose modification, time to permanent discontinuation of all study drugs; Time to abandoning randomized NRTI strategy; Time to virological failure, as defined by the protocol; Binary variable indication if viral load is less than 50 copies/ml; Change in viral load; Binary variable indicating acquisition of drug resistance mutations to any of the study agents; Change in summarized quality of life score; Binomial indicator of "perfect" adherence to assigned ARVs; Change in cardiovascular risk score and fasting lipid values; Change in CD4 count; Time to serious non-AIDS events; Change in virus coreceptor tropism among those with R5-only tropic virus in Step 1; HIV-1 co-receptor tropism; Binary indicator of undetectable CSF HIV-1 RNA; Summarized continuous neuro-cognitive performance Z-scores; Binary variable indicating whether CSF ARV drug concentrations are above the population median; CPE score (CNS penetration effectiveness)
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