Clinical Trials - India

• IMPAACT 2034 - Phase I Study of the Pharmacokinetics, Safety, and Acceptability of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children with Rifampicin-Resistant Tuberculosis

  Study Location: India

  Eligibility: Ages Eligible for Study: up to 17 Years (Child ) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No

  Enrollment: Open

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• A5384: A Phase II, Randomized, Open-Label Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents with Tuberculous Meningitis

  Study Location: India

  Eligibility: Target Participant Age 15 years and older Definite, probable, or possible TBM diagnosis from testing performed as part of...

  Enrollment: Open

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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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• 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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• 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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• 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

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