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 |
---|---|
Closed 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:
PROTOCOL VERSION 2.0- IMPAACT 2010 Protocol Version 2.0 with LoA #1, CM #1, and LoA #2 – 23 August 2019
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IMPAACT 2010 Summary of Changes from V1 to V2 - 8 December 2017
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IMPAACT 2010 Version 2.0 Spanish Sample Informed Consent - 8 January 2018
» Other Study Implementation Documents
» Study Trainings
» DXA Materials
» CMC Resources
Sites where the study is implemented:
CRS ID | Site Name | City | Country |
---|---|---|---|
Gaborone Prevention/Treatment Trials CRS |
Gaborone |
Botswana |
|
Molepolole Prevention/Treatment Trials CRS |
Molepolole |
Botswana |
|
Inst of Pediatrics Fed Univ Rio de Janeiro NICHD CRS |
Rio de Janeiro |
Brazil |
|
Hospital dos Servidores Rio de Janeiro |
Rio de Janeiro |
Brazil |
|
SOM Federal University Minas Gerais Brazil |
Minas Gerais |
Brazil |
|
Hosp. Geral De Nova Iguacu Brazil NICHD CRS |
Rio de Janeiro, Rio de Janeiro |
Brazil |
|
BJ Medical College CRS |
Pune, Maharashtra |
India |
|
Wits RHI Shandukani Research Centre CRS |
Johannesburg |
South Africa |
|
Soweto IMPAACT CRS |
Johannesburg |
South Africa |
|
Family Clinical Research Unit (FAM-CRU) CRS |
Cape Town |
South Africa |
|
CAPRISA Umlazi Clinical Research Site (UKZN) |
Umlazi, KwaZulu-Natal |
South Africa |
|
Kilimanjaro Christian Medical CRS |
Moshi |
Tanzania |
|
Siriraj Hospital Mahidol University CRS |
Bangkok |
Thailand |
|
Chiang Rai Regional Hospital CRS |
Muang |
Thailand |
|
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS |
Chiang Mai |
Thailand |
|
Makerere University - Johns Hopkins University (MU-JHU CARE LTD) Research Collaboration CRS |
Kampala |
Uganda |
|
Baylor-Uganda CRS |
Kampala |
Uganda |
|
University of Miami Pediatric/Perinatal HIV/AIDS |
Miami |
United States of America |
|
University of Florida Jacksonville |
Jacksonville |
United States of America |
|
St. Mary's CRS (Zimbabwe) |
Chitungwiza |
Zimbabwe |
|
Seke North CRS (Zimbabwe) |
Harare |
Zimbabwe |
|
Harare Family Care CRS |
Harare |
Zimbabwe |
Study contacts:
Study Co-Chair: Lameck Chinula |
Study Co-Chair: Shahin Lockman |
DAIDS Medical Officer: Renee Browning |
DAIDS Medical Officer: Patrick Jean-Philippe |
NICHD Medical Officer: Nahida Chakhtoura |
Clinical Trials Specialist: Anne Coletti |
Clinical Trials Specialist: Katie McCarthy |
CAB representative: Nagawa Jaliaah |
Community Program Manager: Cheryl Blanchette |
DAIDS Protocol Pharmacist: Lynette Purdue |
Data Manager: Benjamin Johnston |
Data Manager: Chelsea Krotje |
Investigator: Rivet Amico |
Investigator: Judith Currier |
Investigator: Lee Fairlie |
Investigator: Risa Hoffman |
Investigator: Lewis Holmes |
Investigator: Gaerolwe Masheto |
Investigator: Mark Mirochnick |
Investigator: Jeremiah Momper |
Investigator: Chelsea Morroni |
Investigator: Paul Sax |
Investigator: Roger Shapiro |
Investigator: Lynda Stranix-Chibanda |
Investigator: Jeffrey Stringer |
Laboratory Data Manager (LDM): Kevin Knowles |
Laboratory Data Manager (LDM): Kyle Whitson |
Laboratory Specialist: Frances Whalen |
Laboratory Technologist: Sikhulile Moyo |
Pharmaceutical Company Representative: Manli Chen |
Pharmaceutical Company Representative: Scott McCallister |
Pharmaceutical Company Representative: Brenda Ng |
Pharmaceutical Company Representative: James Rooney |
Pharmaceutical Company Representative: Navdeep Thoofer |
Pharmaceutical Company Representative: Jean van Wyk |
Statistician: Sean Brummel |
Statistician: Lauren Ziemba |
Virologist: Lisa Frenkel |
Westat Representative: Rita Patel |