IMPAACT Study 2010

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
Enrolling	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:

PROTOCOL VERSION 2.0

PROTOCOL VERSION 1.0

» Other Study Implementation Documents

» Study Trainings

» CMC Resources

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