IMPAACT 2010, VESTED, Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants

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 - IMPAACT2010

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/06/014520

Enrollment

549

Registered

2018-06-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- HIV infected pregnant women

Interventions

Intervention1: Dolutegravir Emtricitabine/tenofovir alafenamide Emtricitabine/tenofovir disoproxil fumarate Efavirenz/emtricitabine/tenofovir disoproxil fumarate: Dolutegravir One 50 mg DTG tablet wi

Eligibility

Inclusion criteria

Inclusion criteria: 1 HIV infected pregnant women initiating Antiretroviral medication at 14-28 weeks of gestation 2 18 years of age and ready to give informed consent 3 no evidence of multiple gestation or fetal anomalies

Exclusion criteria

Exclusion criteria: 1Mother is currently incarcerated or involuntarily confined in a medical facility 2A psychoactive medication for treatment of a psychiatric illness 3Treatment for active tuberculosis 4Treatment for active hepatitis C infection

Design outcomes

Primary

Measure	Time frame
roportion of mothers with HIV-1 RNA less than 200 copies/mL at delivery Proportion of mothers with an adverse pregnancy outcome of spontaneous abortion (at 20 weeks gestation), fetal death (at â?¥20 weeks gestation), preterm delivery (37 completed weeks), or small for gestational age (10th percentile using WHO norms)Timepoint: roportion of mothers with HIV-1 RNA less than 200 copies/mL at delivery Measured at delivery	—

Measure

Time frame

roportion of mothers with HIV-1 RNA less than 200 copies/mL at delivery Proportion of mothers with an adverse pregnancy outcome of spontaneous abortion (at 20 weeks gestation), fetal death (at â?¥20 weeks gestation), preterm delivery (37 completed weeks), or small for gestational age (10th percentile using WHO norms)Timepoint: roportion of mothers with HIV-1 RNA less than 200 copies/mL at delivery Measured at delivery

—

Secondary

Measure	Time frame
Proportion of mothers with HIV-1 RNA less than 200 copies/mL Proportion of mothers with HIV-1 RNA less than 50 copies/mL at deliveryTimepoint: Measured at delivery and up to day 14 postpartum	—

Countries

Botswana, India, Thailand, United States of America, Zimbabwe

Contacts

Public ContactNishi Suryavanshi

B J Medical College and Sassoon General Hospitals, Pune

vidyamave@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026