Clinical Trials - Maternal-Child Health and HIV

• 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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• 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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• 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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• 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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• 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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• 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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