Clinical Trials - Tuberculosis and HIV

• 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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• 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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• 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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• 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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• 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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• A5300/P2003: PHOENIx Feasibility Study

  Study Location: India

  Eligibility: Feasibility Study; N/A

  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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• 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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