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

Topic:

HIVHIV PreventionMaternal-Child Health and HIVTuberculosis and HIV

Clinicaltrials.gov Link:

https://clinicaltrials.gov/ct2/show/NCT01253538?term=PROMISE&rank=1

IRB#:

NA_00049859

Coordinator:

Nishi Suryavanshi

Enrollment:

Closed

Trial Period:

Completed

P1078 is a Phase IV, randomized, double-blind, placebo-controlled study of HIV-infected pregnant women and the infants born to the HIV-infected mothers. The study is designed to compare overall safety and toxicity of immediate versus deferred INH preventive therapy in HIV-infected pregnant women enrolled at ≥ 14 through ≤ 34 weeks gestation and by HAART strata.


P1078 Multi-Country Study Team 2016 (Washington DC)

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

Categories

Location
Topic

Clinical Trials

NWCS 408: Examining Longitudinal Cytokine Profiles in HIV-TB...

Using existing data from A5274 and data obtained from retrospectively testing available biospecimens, we propose the following...

Read More

A5322: Long-Term Follow-up of Older HIV-infected Adults in...

The A5322 protocol is a long-term observational study, with a planned series of analyses of data to be collected from an...

Read More

A5300B/I2003B/PHOENIX, Protecting Households On Exposure to...

This study will compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing...

Read More

A5354/EARLIER: Effect of Antiretroviral Treatment Initiated...

This study will include people who have very recently been infected with HIV and will start anti-HIV (antiretroviral) drugs...

Read More

P2001 (DAIDS ID 12026): Evaluating the Pharmacokinetics,...

TB is a major cause of illness and death in women of reproductive age. Pregnant and postpartum women with latent TB are at...

Read More