Clinical Trials - HIV

• P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants

  Study Location: India

  Eligibility: HIV-1-infected pregnant women initiating antiretroviral therapy at 14-28 weeks gestation, and their infants

  Enrollment: Closed

  Read More

• A5207, Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine

  Study Location: India

  Eligibility: Ages Eligible for Study:  13 Years and older   (Child, Adult, Senior) Sexes Eligible for Study:  Female...

  Enrollment: Closed

  Read More

• A5361s: Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE) A5361s: Substudy of REPRIEVE (A5332) Pitavastatin to REduce Physical Function Impairment and FRailty in HIV (PREPARE)

  Study Location: Baltimore

  Eligibility: HIV infected men and women between the ages of 40 and 75 Co-enrolled in REPRIEVE and the Mechanistic (CT) substudy Taking...

  Enrollment: Closed

  Read More

• HPTN083: A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir . . . A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men

  Study Location: Baltimore

  Eligibility: HPTN 083 will enroll approximately 4500 HIV-uninfected MSM and TGW at risk for acquiring HIV infection, ages 18 or older at...

  Enrollment: Closed

  Read More

• A5128: Consent for Use of Stored Patient Specimens for Future Testing

  Study Location: Baltimore

  Eligibility: Genders Eligible for Study:   Both Accepts Healthy Volunteers:   Yes Sampling Method:   Non-Probability Sample...

  Enrollment: Open

  Read More

• A5342: Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)

  Study Location: Baltimore

  Eligibility: Ages Eligible for Study:   18 Years to 65 Years Genders Eligible for Study:   Both Accepts Healthy Volunteers:  ...

  Enrollment: Closed

  Read More

• HPTN 069: A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir disoproxil fumarate (MVC+TDF)

  Study Location: Baltimore

  Eligibility: HIV-uninfected at-risk MSM and at-risk women > 18 years.

  Enrollment: Closed

  Read More

• A5327: Sofosbuvir + Ribavirin w/o Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C)

  Study Location: Baltimore

  Eligibility: Men and women > 18 years, HIV+ and currently on stable antiretroviral (ARV) medications or on for at least 8 weeks and be...

  Enrollment: Closed

  Read More

• A5322: Long-Term Follow-up of Older HIV-infected Adults in the ACTG: Addressing Issues of Aging, HIV Infection and Inflammation – HAILO

  Study Location: Baltimore

  Eligibility: Participants actively followed in the ALLRT (A5001) at the time of enrollment into A5322 or completed follow-up in ALLRT (A5001)...

  Enrollment: Closed

  Read More

• A5314: Effect of LDMTX on Inflammation in HIV-infected Individuals

  Study Location: Baltimore

  Eligibility: HIV-infected men and women ≥40 years old, who have been virologically suppressed on continuous antiretroviral therapy for at...

  Enrollment: Closed

  Read More

• A5225: Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis

  Study Location: India

  Eligibility: HIV-infected males and females ≥16 years of age presenting with their first episode of CM. Participants may not have received...

  Enrollment: Closed

  Read More

• A5273: Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT)

  Study Location: India

  Eligibility: Human immunodeficiency virus (HIV)-1 infected adults (age ≥18 years) who have confirmed virologic failure on an...

  Enrollment: Closed

  Read More

• A5274: REMEMBER, Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens

  Study Location: India

  Eligibility: Participating sites must have a regional TB incidence (i.e., the TB incidence within the site’s expected catchment area)...

  Enrollment: Closed

  Read More

• A5282: A Randomized, Phase II Trial to Compare an HPV Test-and-Treat Strategy to a Cytology-Based Strategy for Prevention of CIN 2+ in HIV-Infected Women

  Study Location: India

  Eligibility: HIV-infected women 18 years of age or older. Eligible participants should have no history of major cervical procedures or...

  Enrollment: Closed

  Read More

• A5288: MULTIOCTAVE, Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure

  Study Location: India

  Eligibility: HIV-1-infected males and females at non-US sites, aged ≥18 years, who have experience with or resistance to NRTIs, NNRTIs,...

  Enrollment: Closed

  Read More

• P1060:  Phase II, parallel, randomized, clinical trials comparing the responses to initiation of NNRTI-based antiretroviral therapy in HIV-infected infants who have not previously received Single dose Nevirapine for prevention of Mother-to-child HIV transmission

  Study Location: India

  Eligibility: HIV-infected infants and children ≥ 2 months to < 36 months of age who are eligible for ART as defined by the WHO...

  Enrollment: Closed

  Read More

• P1073: Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children < 72 Months of Age

  Study Location: India

  Eligibility: Ages Eligible for Study:  up to 72 Months   (Child) Sexes Eligible for Study:  All Accepts Healthy Volunteers:...

  Enrollment: Closed

  Read More

• P1077BF: Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

  Study Location: India

  Eligibility: Antepartum component - Pregnant HIV-infected women who intend to breastfeed and their infants. Late Presenters - Late...

  Enrollment: Closed

  Read More

• P1077FF: Formula Feeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

  Study Location: India

  Eligibility: Antepartum Component – HIV-infected pregnant women who intend to formula feed (FF) (with and without HBV) with documented...

  Enrollment: Closed

  Read More

• P1078: A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB Incidence Settings

  Study Location: India

  Eligibility: Mother/infant pairs: HIV-infected pregnant women ≥ 14 weeks through ≤ 34 weeks (34 weeks, 6 days) gestation.

  Enrollment: Closed

  Read More