Clinical Trials -
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Identification of Biomarkers That Can Predict Progression from Latent Tuberculosis Infection to Active Tuberculosis Disease
Study Location: India
Eligibility: Adult, Pediatric, Household contacts
Enrollment: Open
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ACTIV-2/A5401: Adaptive Platform Treatment for Outpatients with COVID-19 (Adapt Out COVID)
Study Location: BaltimoreIndia
Eligibility: Adults
Enrollment: Open
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P2026: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum
Study Location: BaltimoreIndia
Eligibility: Preg/postpartum women. Infants
Enrollment: Open
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The Pharmacokinetics, Safety and Acceptability of New Child-Friendly Formulations of Clofazimine and Moxifloxacin in Children Routinely Treated for Rifampicin-Resistant Tuberculosis (CATALYST)
Study Location: India
Eligibility: Pediatrics
Enrollment: Open
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Impact of Tuberculosis Infection on HIV-1 Antibody Response (NWCS501)
Study Location: BaltimoreIndia
Eligibility: Adults, adolescents
Enrollment: Open
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A5300B/I2003B/PHOENIX, Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Study Location: India
Eligibility: Men and women age greater than or equal to 18 year
Enrollment: Open
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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
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P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with OBR for MDR-TB in HIV-Infected and Uninfected Children with MDR-TB
Study Location: India
Eligibility: HIV-infected and HIV-uninfected infants, children, and adolescents less than 18 years of age with confirmed or probable MDR-TB.
Enrollment: Open
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A5253: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
Study Location: India
Eligibility: Ages Eligible for Study: 13 Years and older (Child, Adult, Senior) Sexes Eligible for Study: All Accepts...
Enrollment: Closed
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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
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P1070, Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and Children ≥ 3 Months to < 36 Months of Age
Study Location: India
Eligibility: Ages Eligible for Study: 3 Months to 35 Months (Child) Sexes Eligible for Study: All Accepts Healthy...
Enrollment: Closed
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A5290, A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis Treatment with or without Raltegravir in HIV-1-Infected Persons Requiring Treatment for Active TB and HIV
Study Location: India
Eligibility: Ages Eligible for Study: 18 Years and older (Adult, Senior) Sexes Eligible for Study: All Accepts Healthy...
Enrollment: Closed
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A5279, Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-infected Individuals with Latent Tuberculosis Infection
Study Location: India
Eligibility: Ages Eligible for Study: 13 Years and older (Child, Adult, Senior) Sexes Eligible for Study: All Accepts...
Enrollment: Closed
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A5302: BioBank for Surrogate Marker Research for TB (B-SMART)
Study Location: India
Eligibility:
Enrollment: Closed
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NWCS 445: Novel Biomarkers to Shorten TB Treatment NWCS 445: Novel Biomarkers to Shorten TB Treatment: A Substudy of S31/A5349
Study Location: India
Eligibility: Partncipants enrolled in “Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: a randomized,...
Enrollment: Closed
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NWCS 414, Evaluation of a Serum Biosignature for Identifying HIV-infected Individuals at Greatest risk for Developing Active TB
Study Location: India
Eligibility: N/A
Enrollment: Closed
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P1108: A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) in Combination with Optimized Individualized Multidrug-Resistant Tuberculosis (MDR-TB) Therapy in HIV-Infected and HIV-Uninfected Infants, Children and Adolescents with MDR-TB Disease
Study Location: India
Eligibility: Ages Eligible for Study: up to 18 Years (Child, Adult) Sexes Eligible for Study: All Accepts Healthy...
Enrollment: Open
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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
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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
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P2001 (DAIDS ID 12026): Evaluating the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-1-Infected and HIV-1-Uninfected Pregnant and Postpartum Women With Latent Tuberculosis Infection
Study Location:
Eligibility: Ages Eligible for Study: 18 Years and older (Adult, Senior) Sexes Eligible for Study: Female Accepts...
Enrollment: Closed
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NWCS 408: Examining Longitudinal Cytokine Profiles in HIV-TB Co-infected Participants Examining Longitudinal Cytokine Profiles in HIV-TB Co-infected Participants to Study the Exit from Latent TB Infection and Death: A Supplemental Proposal for A5274
Study Location: India
Eligibility:
Enrollment: Closed
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A5349: Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial (TBTC S31)
Study Location: India
Eligibility: Ages Eligible for Study: 12 Years and older (Child, Adult, Senior) Genders Eligible for Study: Both Accepts...
Enrollment: Closed
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A5350: Effects of Visbiome Extra Strength on Gut Microbiome and Immune Activation Markers
Study Location:
Eligibility: Participants in the study must: Have HIV infection Be on stable HIV treatment for at least the last 24 weeks Have...
Enrollment: Closed
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HPTN 078: Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States
Study Location: Baltimore
Eligibility: Ages Eligible for Study: 16 Years and older Genders Eligible for Study: Male Accepts Healthy Volunteers: ...
Enrollment: Closed
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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
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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
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A5300/P2003: PHOENIx Feasibility Study
Study Location: India
Eligibility: Feasibility Study; N/A
Enrollment: Closed
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A5332: Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)
Study Location: BaltimoreIndia
Eligibility: HIV infected men and women between the ages of 40 and 75 On HIV medications for at least 6 months CD4 cell count greater...
Enrollment: Closed
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A5329: Interferon –Free Therapy for Chronic Hepatitis C Virus Genotype 1 infection in persons with HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy: A5334s Pharmacokinetic Substudy
Study Location: Baltimore
Eligibility: HIV and Hepatitis C co-infected people 18 to 70 years old HIV viral load less than 50 copies Currently on one of the...
Enrollment: Closed
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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
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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
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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
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A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intensification or Intensification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
Study Location: Baltimore
Eligibility: Men and women > 18 years old who have HIV-associated neurocognitive disorder (HAND) as defined by the Frascati...
Enrollment: Open
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A5320: Viral Hepatitis C Infection Long-term Cohort Study (V-HICS)
Study Location: Baltimore
Eligibility: Men and women ≥ 18 years old, HCV/HIV-1 coinfected who failed HCV therapy any time after HCV/DAA treatment discontinuation...
Enrollment: Closed
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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