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IMPAACT 2010 / VESTED

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

Participants Off Study and Primary Analysis Completed

DAIDS Number

30129

IND Number

133,438

Clinical Trials Link

Summary

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.

IMPAACT 2010 Randomization
ARVs with EFV and DTG combinations

Abstracts

Genotypic and Phenotypic Dolutegravir Resistance in Pregnant Women and Children Living with HIV-1

Study

IMPAACT 2010, P1093

Authors

CL Boyce, RA Smith, R Nixon, MD Bishop, SM Styrchak, K Knowles, S Brummel, TD Ruel, A Wiznia, S Lockman, L Chinula, PK Drain, GS Gottlieb, LM Frenkel

Growth of Breastfed Infants Exposed In Utero to Maternal DTG vs EFV and TDF vs TAF

Conference

CROI 2022

Study

IMPAACT 2010

Authors

Lynda Stranix-Chibanda, Lauren Ziemba, Sean Brummel, Ben Johnston, Tapiwa Mbengeranwa, Haseena Cassim, Gerhard Theron, Zukiswa Ngqawana, Deo Wabwire, Katie McCarthy, Nahida Chakhtoura, Patrick Jean-Philippe, Lameck Chinula, Shahin Lockman, IMPAACT 2010/VESTED study team and investigators

Risk-benefit Trade-off for Pregnancy and Infant Outcomes: DTG, EFV, TAF, and TDF

Conference

CROI 2022

Study

IMPAACT 2010

Authors

Sean S Brummel, Lauren Ziemba, Anne Coletti, Lameck Chinula, Chelsea Krotje, Renee Browning, Patrick Jean Philippe, Nahida Chakhtoura, Esaú Custódio João, Mpho Raesi, James Samwel Ngocho, Linda Aurpibul, Lynda Stranix-Chibanda, Roger Shapiro, Jeff Stringer, Shahin Lockman

HIV DRUG RESISTANCE IN WOMEN RANDOMIZED TO DTG VS EFV OR TDF VS TAF IN PREGNANCY

Conference

CROI 2022

Study

IMPAACT 2010

Authors

Ceejay Boyce, Sean Brummel, Lauren Ziemba, Katie McCarthy, Kevin Knowles, Sheila Styrchak, Renee Browning, Nahida Chakhtoura, Sikhulile Moyo, Tichaona Vhembo, Violet Korutaro, Jose Henrique Pilotto, Lameck Chinula, Shahin Lockman, Lisa M. Frenkel

Adverse Outcomes in Subsequent Pregnancies in IMPAACT 2010 Trial

Conference

CROI 2022

Study

IMPAACT 2010

Authors

Lee Fairlie, Sean Brummel, Sean Brummel, Anne Coletti, Lameck Chinula, Roger Shapiro, Jeff Stringer, Renee Browning, Nahida Chakhtoura, Blandina Theophil Mmbaga, Tsungai P Mhembere, Gaerolwe Masheto, Beatrice Nagaddya, Megeshinee Naidoo, Shahin Lockman