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 3
- Conditions
- Health Condition 1: null- HIV infected pregnant women
- Registration Number
- CTRI/2018/06/014520
- Lead Sponsor
- IH DAIDS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method roportion of mothers with HIV-1 RNA less than 200 copies/mL at delivery <br/ ><br>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 <br/ ><br>Measured at delivery
- Secondary Outcome Measures
Name Time Method Proportion of mothers with HIV-1 RNA less than 200 copies/mL <br/ ><br>Proportion of mothers with HIV-1 RNA less than 50 copies/mL at deliveryTimepoint: Measured at delivery and up to day 14 postpartum