P1026s (10040): Pharmacokinetic Properties of Antiretroviral Therapy During Pregnancy

Study Status Study Restriction

Enrolling

US & Non-US

What is P1026s?

P1026s is a Phase IV, prospective pharmacokinetic (PK) study of selected ARV drugs currently used in the clinical care of HIV-infected pregnant women during pregnancy and postpartum.  This study is designed to evaluate the following: the pharmacokinetics of antiretroviral medicines when used alone or co-administered with tuberculosis medicines during pregnancy; the pharmacokinetic parameters of lopinavir/ritonavir and atazanavir/ritonavir/tenofovir in women postpartum before and after starting hormonal contraceptives; and the concentrations of ethinyl estradiol, etonogestrel and other progestins in women using hormonal contraceptives and protease inhibitors.

Study documents:

PROTOCOL VERSION 10.0 PROTOCOL VERSION 9.0
      Please note - as of November 2016, the South African Department of Health has requested that all import permit applications be accompanied by either an MTA or a letter from the country of origin, indicating their knowledge about the export. Please contact Jennifer Norman (jennifer.norman@uct.ac.za) with any questions.

Sites where the study is implemented:

CRS ID Site Name City Country

5082

Hospital General de Agudos Buenos Aires Argentina NICHD CRS

Buenos Aires

Argentina

5082

Hospital General de Agudos Buenos Aires Argentina NICHD CRS

Buenos Aires

Argentina

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

Botswana

5071

Inst of Pediatrics Fed Univ Rio de Janeiro NICHD CRS

Rio de Janeiro

Brazil

5072

Hospital dos Servidores Rio de Janeiro

Rio de Janeiro

Brazil

5073

SOM Federal University Minas Gerais Brazil

Minas Gerais

Brazil

5074

Univ of Sao Paulo Brazil

Sao Paulo

Brazil

5097

Hosp. Geral De Nova Iguacu Brazil NICHD CRS

Rio de Janeiro, Rio de Janeiro

Brazil

5098

Hospital Santa Casa Porto Alegre Brazil NICHD CRS

Rio Grande do Sul

Brazil

30022

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

Port-au-Prince

Haiti

8051

Shandukani Research CRS

Johannesburg

South Africa

8950

Stellenbosch University

Cape Town

South Africa

31790

Desmond Tutu TB Centre - Stellenbosch University (SU) CRS

Cape Town

South Africa

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

5115

Siriraj Hospital Mahidol University CRS

Bangkok

Thailand

5116

Chiang Rai Regional Hospital CRS

Muang

Thailand

31784

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai

Thailand

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

3801

Texas Childrens Hosp. CRS

Houston

United States of America

4001

Chicago Children's CRS

Chicago

United States of America

4201

University of Miami Pediatric/Perinatal HIV/AIDS

Miami

United States of America

4601

UCSD Mother-Child-Adolescent HIV Program

San Diego

United States of America

5011

Boston Medical Center Pediatric HIV Program

Boston

United States of America

5013

Jacobi Medical Center Bronx

Bronx

United States of America

5017

Univ of Washington Children's Hospital Seattle

Seattle

United States of America

5029

Univ of Washington NICHD CRS

Seattle

United States of America

5030

Emory University School of Medicine NICHD CRS

Atlanta

United States of America

5031

San Juan City Hospital

San Juan

United States of America

5040

SUNY Stony Brook

Stony Brook

United States of America

5048

University of Southern California LA

Los Angeles

United States of America

5052

University of Colorado Denver NICHD CRS

Aurora

United States of America

5083

Rush University Cook County Hospital Chicago NICHD CRS

Chicago

United States of America

5092

Johns Hopkins University, Baltimore

Baltimore

United States of America

5112

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR

Los Angeles

United States of America

5113

The Children's Hospital of Philadelphia

Philadelphia

United States of America

5114

Bronx-Lebanon Hospital IMPAACT

Bronx

United States of America

6501

St. Jude/UTHSC CRS

Memphis

United States of America

6601

University of Puerto Rico Pediatric HIV/AIDS Research Program CRS

San Juan

United States of America

Study contacts:

Study Chair: Mark Mirochnick

Study Vice-Chair: Brookie Best

Study Vice-Chair: Alice Stek

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Nahida Chakhtoura

Clinical Trials Specialist: Kathleen George

Data Manager: Benjamin Johnston

Field Representative: Emily Barr

Field Representative: Pra-Ornsuda Sukrakanchana

Investigator: Adrie Bekker

Investigator: Nantasak Chotivanich

Investigator: Anthony Garcia-Prats

Investigator: Amita Gupta

Investigator: Anneke Hesseling

Investigator: Gonzague Jourdain

Investigator: Regis Kreitchmann

Investigator: Pooja Mehta

Investigator: Marije Van Schalkwyk

Laboratory Data Manager (LDM): Alexander Benns

Laboratory Data Manager (LDM): Katelyn Hergott

Laboratory Technologist: Kittipong Rungruengthanakit

Pediatrician: Sandra Burchett

Pharmacologist: Edmund Capparelli

Pharmacologist: Timothy Cressey

Proposal Statistician: Jiajia Wang

Senior Statistician: David Shapiro

Virologist: Lisa Frenkel

Westat Representative: Rita Patel

 

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.