P1078 (DAIDS ID 10732): 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 Status Study Restriction

Closed to Follow Up

Non-US

What is P1078?

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.

Study Documents:

PROTOCOL VERSION 2.0

Additional Study Implementation Documents

Sites where the study is implemented:

CRS ID Site Name City Country

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

Botswana

30022

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS

Port-au-Prince

Haiti

31441

BJ Medical College CRS

Pune, Maharashtra

India

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Family Clinical Research Unit (FAM-CRU) CRS

Cape Town

South Africa

31790

Desmond Tutu TB Centre - Stellenbosch University (SU) CRS

Cape Town

South Africa

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

31784

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai

Thailand

30293

Makerere University - Johns Hopkins University (MU-JHU CARE LTD) Research Collaboration CRS

Kampala

Uganda

30303

St. Mary's CRS (Zimbabwe)

Chitungwiza

Zimbabwe

30306

Seke North CRS (Zimbabwe)

Harare

Zimbabwe

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Chair: Amita Gupta

Study Vice-Chair: Timothy Sterling

Study Vice-Chair: Gerhard Theron

Study Vice-Chair: Adriana Weinberg

DAIDS Medical Officer: Renee Browning

NICHD Medical Officer: Nahida Chakhtoura

Clinical Trials Specialist: Sarah Bradford

Clinical Trials Specialist: Katie McCarthy

Community Program Manager: Cheryl Blanchette

Consultant: Vivian Rexroad

Data Manager: Bonnie Zimmer

Field Representative: Joan Coetzee

ICAB Representative: Ujwala Kadam

Immunologist: Susanne Doblecki-Lewis

Immunologist: Savita Pahwa

Investigator: Monica Gandhi

Investigator: Jyoti Mathad

Investigator: Mark Sonderup

Investigator: Stephen Spector

Laboratory Data Manager (LDM): Rebecca LeBlanc

Laboratory Data Manager (LDM): Kyle Whitson

Laboratory Specialist: Diane Costello

Laboratory Specialist: Susan Fiscus

Laboratory Specialist: Amy James Loftis

Laboratory Technologist: Vandana Kulkarni

Pharmacologist: Francesca Aweeka

Pharmacologist: Peter Smith

Protocol Pharmacist: Katherine Shin

Statistician: Lisa Aaron

Statistician: Grace Montepiedra

Virologist: Grace Aldrovandi

Westat Representative: Scott Watson

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.