IMPAACT 2010: 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 Status Study Restriction

Open to Accrual

US & Non-US

What is IMPAACT 2010 (VESTED)?

IMPAACT 2010 is a Phase III, three-arm, randomized, open-label study of HIV-1-infected pregnant women initiating either a dolutegravir-containing antiretroviral regimen or an efavirenz-containing antiretroviral regimen at 14-28 weeks gestation. The VESTED study (Virologic Efficacy and Safety of ART Combinations with TAF/TDF, EFV, and DTG) will compare the regimens with regard to safety and virologic efficacy during pregnancy and through 50 weeks of maternal and infant follow-up postpartum.

Study Documents:

» Other Study Implementation Documents

» Study Trainings


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

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

5097

Hosp. Geral De Nova Iguacu Brazil NICHD CRS

Rio de Janeiro, Rio de Janeiro

Brazil

30022

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

Port-au-Prince

Haiti

31441

BJ Medical College CRS

Pune, Maharashtra

India

12001

University of North Carolina Lilongwe CRS

Lilongwe

Malawi

30301

College of Medicine JHU CRS

Blantyre

Malawi

8051

Wits RHI Shandukani Research Centre CRS

Johannesburg

South Africa

8052

Soweto IMPAACT CRS

Johannesburg

South Africa

8950

Family Clinical Research Unit (FAM-CRU) CRS

Cape Town

South Africa

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

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 CARE LTD) Research Collaboration CRS

Kampala

Uganda

31798

Baylor-Uganda CRS

Kampala

Uganda

4201

University of Miami Pediatric/Perinatal HIV/AIDS

Miami

United States of America

5051

University of Florida Jacksonville

Jacksonville

United States of America

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 Co-Chair: Lameck Chinula

Study Co-Chair: Shahin Lockman

DAIDS Medical Officer: Patrick Jean-Philippe

NICHD Medical Officer: Nahida Chakhtoura

Clinical Trials Specialist: Anne Coletti

Clinical Trials Specialist: Katie McCarthy

Community Program Manager: Cheryl Blanchette

DAIDS Protocol Pharmacist: Lynette Purdue

Data Manager: Benjamin Johnston

Data Manager: Chelsea Krotje

Investigator: Judith Currier

Investigator: Lee Fairlie

Investigator: Risa Hoffman

Investigator: Gaerolwe Masheto

Investigator: Mark Mirochnick

Investigator: Jeremiah Momper

Investigator: Paul Sax

Investigator: Roger Shapiro

Investigator: Lynda Stranix-Chibanda

Investigator: Jeffrey Stringer

Laboratory Data Manager (LDM): Andee Fox

Laboratory Specialist: William Murtaugh

Laboratory Technologist: Sikhulile Moyo

Pharmaceutical Company Representative: Maja Cruz

Pharmaceutical Company Representative: Scott McCallister

Pharmaceutical Company Representative: Brenda Ng

Pharmaceutical Company Representative: James Rooney

Pharmaceutical Company Representative: Navdeep Thoofer

Statistician: Paula Britto

Statistician: Sean Brummel

Statistician: Lauren Ziemba

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.