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Clinical Trial
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TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients
NCT00896051
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Tibotec Pharmaceuticals Clinical Trial, IRELAND
Recruiting: Orlando, Tampa, Vero Beach, West Palm Beach
This study is ongoing, but not recruiting participants.
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PK interaction between ETR and ATV/rtv at 2 different doses; safety & tolerability of ETR in combination with ATV/rtv and 1 NRTI over 48 weeks.; Assessing the impact of cytochrome P450 (CYP) 2C9 and 2C19 genotypes on ETR PK; Evaluating safety and tolerability of ETR in combination with ATV/r and 1 NRTI over 48 weeks; Evaluating the antiviral activity of ETR and ATV/r with 1 NRTI over 48 weeks; Evaluating the immunologic changes (as measured by CD4 cells) with ETR and ATV/r with 1 NRTI over 48 weeks; Evaluating changes in viral genotype and drug susceptibility
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Clinical Trial
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Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults.
NCT01309243
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Alena Jandourek, M.D. Gilead Sciences
This study is ongoing, but not recruiting participants
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The primary efficacy endpoint is the proportion of subjects who achieve HIV 1 RNA < 50 copies/mL at week 48; The change from baseline in CD4 count in each treatment arm at week 48; The change from baseline in CD4 count in each treatment arm at week 96
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Clinical Trial
Behavioral/Epidemiological
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Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
NCT00992017
The recruitment status of this study is unknown because the information has not been verified recently
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National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Sharon Nachman, MD, State University of New York at Stony Brook
Pfizer CT.gov Call Center
Contact: Carolyn Graisbery, RN 727-767-8450 cgraisbe@hsc.usf.edu
Contact: Patricia Bryan
305-243-4447 pbryan@med.miami.edu
Principal Investigator: Gwendolyn B. Scott, MD
Contact: Kathleen Thoma, MPH 904-244-5331 kathleen.thoma@jax.ufl.edu
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Adverse events (AEs) of all grades; AEs of all grades attributed to the study vaccine; Withholding of second vaccine dose due to adverse reactions attributed to first dose; Immunologic response, defined as hemagglutination inhibition (HAI) titer of at least 1:40; Maternal immunologic response, defined as HAI of at least 1:40; Infant HAI of at least 1:40; Maternal geometric mean titers (GMT) of antibodies HAI; Infant GMT of antibodies HAI; Maternal cell-mediated immunity (CMI) responses, as measured by B-cell and T-cell enzyme-linked immunosorbent spot (ELISPOT) assay values; CD4 count; HIV RNA copies/ml; Response to seasonal trivalent influenza vaccine (TIV); Exploration of factors related to HIV and its treatment that might affect the response to H1N1 vaccinations
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Clinical Trial
Behavioral/Epidemiological
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Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women
NCT00604175
This study is ongoing, but not recruiting participants.
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National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Dental and Craniofacial Research (NIDCR)
Erna Milunka Kojic, MD, Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University;
Susan Cu-Uvin, MD, Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University
Study Chair: Erna Milunka Kojic, MD
Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University
Study Chair: Susan Cu-Uvin, MD
Obstetrics-Gynecology and Medicine, The Miriam Hospital, Brown University
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Type-specific HPV antibody development from the seronegative status at baseline to seropositive status a month after the completion of HPV vaccination series (Week 28) for HPV types 6, 11, 16, and 18; Occurrence of Grade 3 or greater adverse events; HPV antibody titers to types 6, 11, 16, 18; Longitudinal changes in HIV viral load; Nadir and baseline CD4 count; Baseline HIV viral load; Cellular immune response assay data from the subset of U.S. participants; Longitudinal changes in CD4+ cell count from baseline
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Clinical Trial
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An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
NCT00791700
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VIIV Healthcare
Pfizer CT.gov Call Center
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Recruiting: Jacksonville, Miami, St. Petersburg, Tampa
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To determine the safety and tolerability of maraviroc in HIV-infected children and adolescents.; To determine the pharmacokinetic profile(s) and dosing schedule(s) for maraviroc in treatment experienced HIV-infected children and adolescents on different background therapies;; Describe the efficacy of multiple dose administration of maraviroc in treatment experienced children infected with CCR5 tropic HIV-1;; Describe tropism changes over time.
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Clinical Trial
Basic Science/Virology
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Safety and Effectiveness of Raltegravir (MK-0518) in Treatment-Experienced, HIV-Infected Children and Adolescents
NCT00485264
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National Institute of Allergy and Infectious Diseases (NIAID)
Study Chair: Sharon A. Nachman, MD State University of New York at Stony Brook, Health Science Center
Study Chair: Andrew Wiznia, MD
Jacobi Medical Center, Albert Einstein College of Medicine
Contact: Amy L Inman, BS 954-728-1050 ainman@nbhd.org
Contact: Zulma Eysallenne, R.N. 954-728-1125 Zeysallenne@browardhealth.org
Contact: Chas Griggs, MEd, CCRP 904-244-5331 chas.griggs@jax.ufl.edu
Principal Investigator: Mobeen H Rathore, MD
Contact: Liset Taybo, MD 305-243-4445 LTaybo@med.miami.edu
Principal Investigator: Gwendolyn B. Scott, MD
Contact: Tammy A. Myers 813-259-8786 Tmyers@health.usf.edu
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Termination from treatment due to suspected drug reaction attributable to the study medication; Grade 3 or 4 adverse events; Pharmacokinetic parameters; HIV viral load; CD4 count and percentage; Genotypic and phenotypic resistance measures
Recruiting: Jacksonville, Miami, Ft. Lauderdale, Tampa
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Clinical Trial
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The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs.
NCT00354627
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Study Director, Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited and IREL
This treatment has been approved for sale to the public.
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The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral (ARV) regimens. Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed. Available data regarding the effectiveness of the drug will also be collected. To be eligible, patients should be failing their current ARV regimen or be on a treatment interruption, should have previously received 2 different protease inhibitor (PI) containing regimens and be at least 3-class experienced (protease inhibitors [PI], nucleoside/tide reverse transcriptase inhibitors [N[t]RTIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) or at least 2-class experienced (PIs and N[t]RTIs) with primary NNRTI resistance. TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications.
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Clinical Trial
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A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)
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GSK Clinical Trials and VIIV Healthcare
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To determine the proportion of subjects who maintain HIV-1 RNA <50 copies/mL through Week 24; Number of patients with adverse events as a measure of safety and tolerability in each treatment arm; To assess change from baseline in HIV-1 RNA and CD4+ cell count in each arm; To compare change from baseline in fasting lipid parameters (triglycerides, total cholesterol, LDL- and HDL-cholesterol)
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Clinical Trial
Behavioral/Epidemiological
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Pharmacokinetic Study of Anti-HIV Drugs During Pregnancy
NCT00042289
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National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Mark Mirochnick, MD, Boston Medical Center
Contact: Emily F. Demske
301-628-3322
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The purpose of this study is to determine what doses of anti-HIV medications are appropriate for pregnant women.
Anti-HIV medication taken during pregnancy may control a woman's viral load and reduce the chance that the baby will become infected with HIV. Pregnant women may require different doses of anti-HIV drugs than women who are not pregnant. This study will use pharmacokinetic (PK) sampling to determine what doses of anti-HIV medications are best for HIV-infected pregnant women and their infants.
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Clinical Trial
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Study to Evaluate Switching From Regimens Consisting of Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed Dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF
NCT01252940
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John Flaherty, PharmD, Gilead Sciences
This study is ongoing, but not recruiting participants.
Responsible Party:
Todd Fralich, MD, Director, Medical Affairs, Gilead Sciences
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The purpose of this study is to evaluate the non-inferiority of FTC/RPV/TDF fixed dose regimen (FDR) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI/r)and two nucleoside reverse transcriptase inhibitors (NRTIs). The FDR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment.
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Clinical Trial
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Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
NCT01049217
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Pfizer CT.gov Call Center
Contact: Pfizer CT.gov Call Center 1-800-718-1021
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The purpose of this study is to evaluate the efficacy of pregabalin compared to placebo in reducing neuropathic pain associated with HIV neuropathy.
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Clinical Trial
Behavioral/Epidemiological
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An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251)
NCT01145417
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Pfizer CT.gov Call Center
Contact: Pfizer CT.gov Call Center 1-800-718-1021
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This study examines the safety of pregabalin over a 6 month period in patients with neuropathic pain associated with HIV infection as an extension of another trial that tests the efficacy of pregabalin.
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Clinical Trial
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A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults
NCT01231516
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Sherene Min, Project Physician Lead GSK Clinical Trials
Shionogi
ViiV Healthcare
Contact: US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com
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ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated
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Clinical Trial
Behavioral/Epidemiological
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High Dose Chemotherapy With Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients (BMT CTN 0803)
NCT01141712
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Joseph Alvarnas, MD, City of Hope National Medical Center
Richard Ambinder, MD, Johns Hopkins Medical Institution
National Heart, Lung, and Blood Institute (NHLBI); National Cancer Institute (NCI); Blood and Marrow Transplant Clinical Trials Network
Contact: Mary Horowitz, MD, MS 414-805-0700
marymh@mcw.edu
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This study is a Phase II, multicenter trial assessing overall survival after autologous hematopoietic stem cell transplantation using a BEAM transplant regimen in lymphoma patients with HIV.
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Contact: John Wingard, MD 352-273-8022
wingajr@medicine.ufl.edu
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33624
Contact: Ernesto Alaya, MD 813-745-1554
ernesto.ayala@moffitt.org
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Clinical Trial
Behavioral/Epidemiological
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Perinatal Core Protocol
(Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission)
NCT00028145
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Ruth Tuomala, MD,
Director of Obstetrics and Gynecology, Brigham and Women's Hospital; Gwen Scott, MD, Pediatric Infectious Diseases, University of Miami School of Medicine
International Maternal Pediatric Adolescent AIDS Clinical Trials Group; Nat’l Inst. of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
North Broward Hosp District
Fort Lauderdale, Florida, 33311
Contact: Deanna Cruz
954-728-1125
dcruz@nbhd.org
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
Contact: Michelle Eagle
904-244-5331
michelle.eagle@jax.ufl.edu
Univ of Miami (Pediatric)
Miami, Florida, 33136
Contact: Patricia Bryan
305-243-4447
Jackson Memorial Hosp
Miami, Florida, 33136
Contact: Patricia Bryan
305-243-4447
PBryan@med.miami.edu
University of South Florida at Tampa
St Petersburg, Florida,
Contact: Carolyn Graisbery, RN
727-892-4184
cgraisbe@hsc.usf.edu
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The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their children.
The rate of transmission of HIV from mothers to their infants has gone down. Specific U.S. Public Health Service guidelines recommend that HIV-infected pregnant women be treated with anti-HIV therapies; but the effectiveness of treatment and safety for the mother and her infant have not been fully examined. This study will monitor the health of women and their infants while they receive anti-HIV therapy. Also, this study will provide information that may be used for future studies.
Investigators
Study Chair: Ruth Tuomala, MD
Director of Obstetrics and Gynecology,
Brigham and Women's Hospital
Study Chair: Gwen Scott, MD
Pediatric Infectious Diseases,
University of Miami School of Medicine
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Clinical Trial
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Emergency Use Program for Highly Treatment-Experienced HIV+ Patients
(Emergency Use Program for HTE HIV+ Patients Who Need Tipranavir Treatment)
NCT00062660
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Boehringer Ingelheim
Pharmaceuticals
Contact: Boehringer Ingelheim Call Center
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
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To provide early access to tipranavir and evaluate the safety and tolerance of tipranavir combined with low dose of ritonavir in patients with progressive, HIV-1 disease who have failed or are intolerant to currently approved treatments for HIV infection, who are unable to participate in another tipranavir controlled clinical trial and have an urgent need for anti-HIV treatment.
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Clinical Trial
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Connect To Protect® Partnerships for Youth Prevention Interventions: Phase III
NCT00271908
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute on
Drug Abuse (NIDA); National Institute of
Mental Health (NIMH); National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Jonathan Ellen, MD,Johns Hopkins University Hospital
This study has been completed as of 09-05-11
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Connect to Protect (C2P): Partnerships for Youth Prevention Interventions is a multi-site, three-phase project developed by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). The overall goal of the project is to ultimately reduce HIV incidence and prevalence in youth 12-24 years old through a community mobilization intervention. This protocol (ATN 040) describes part one of Phase III. Part two of Phase III will be submitted as a separate protocol (ATN 041).
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Clinical Trial
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A Phase 1/2, Open Label, Single Infusion Study of Autologous T-Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases (SB-728-T) in HIV Infected Subjects
NCT01252641
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SANGAMO Biosciences
Winson Tang, M.D., Sangamo BioSciences, Inc.
Contact: Ya-Li Lee
ylee@sangamo.comContact: Shelley Wang, MD, Ph.D
swang@sangamo.com
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This research study is being carried out to study a new way to possibly treat human immunodeficiency virus (HIV). The agent is called SB-728-T which are CD4+ T-cells obtained from an individual that are genetically modified at the CCR5 gene by Zinc Finger Nucleases. The CCR5 gene is required for certain types of HIV to enter into and infect T-cells. T cells are one of the white blood cells used by the body to fight HIV. The most important of these are called "CD4+ T-cells"
Some people are born without the CCR5 gene on their T-Cells. These people remain healthy and are resistant to infection with HIV. Other people have a low number of CCR5 genes on their T-cells and their HIV disease is less severe and is slower to cause disease (AIDS). The purpose of this research study is to find out whether SB-728-T is safe to give to humans and find out how this affects HIV.
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Clinical Trial
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A Phase 2B Open Label Pilot Study to Evaluate Switching From a Regimen Consisting of a Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Single Tablet Regimen (STR) to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) STR in Virologically Suppressed, HIV 1 Infected Subjects
NCT01286740
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Alena Jandourek, MD,
Gilead Sciences
Alena Jandourek, MD, Dir, Clinical Research, Gilead Sciences
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