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

> **NCT03048422** · PHASE3 · COMPLETED · sponsor: **National Institute of Allergy and Infectious Diseases (NIAID)** · enrollment: 643 (actual)

## Conditions studied

- HIV Infections

## Interventions

- **DRUG:** Dolutegravir
- **DRUG:** Emtricitabine/tenofovir alafenamide
- **DRUG:** Emtricitabine/tenofovir disoproxil fumarate
- **DRUG:** Efavirenz/emtricitabine/tenofovir disoproxil fumarate

## Key facts

- **NCT ID:** NCT03048422
- **Lead sponsor:** National Institute of Allergy and Infectious Diseases (NIAID)
- **Sponsor class:** NIH
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-01-19
- **Primary completion:** 2020-10-03
- **Final completion:** 2020-10-03
- **Target enrollment:** 643 (ACTUAL)
- **Last updated:** 2022-11-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03048422

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03048422, "Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03048422. Licensed CC0.

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