Safety and efficacy of Dolutegravir and EFV400 for pregnant and breastfeeding women: a randomized non-inferiority clinical trial

Phase 4

Recruiting

• Conditions: HIV/AIDS

• Registration Number: PACTR201909810587438
• Lead Sponsor: Hawassa University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 1830

Inclusion Criteria

HIV infected pregnant women who are in their 2nd trimester of pregnancy in Ethiopian and Ugandan
recruitment sites.
- HIV infected pregnant women who are older than 18 years of age
- ART naïve HIV infected pregnant women or women who are on first-line ART during 2nd trimester of
pregnancy irrespective of the duration on ART and are willing to be switched to the regimen they are
assigned to.
- Ability to stay in regular follow up during the duration of pregnancy, delivery and during breast feeding; and,
- Consenting to exclusively breastfeed, continue participating in the study during breastfeeding, and to allow
their infants to participate in the study.
- Consenting to use mandatory long-acting contraception for 48 months post-partum for women assigned to
the DTG arm.

Exclusion Criteria

- Being on second-line ART during the first trimester of pregnancy
- Presence of co-infection (such as TB) and chronic illnesses including diabetes mellitus (DM), hypertension
and cardiac diseases, and bad obstetric history including miscarriage or early neonatal death
- Not consenting to participate or to be on long-acting contraception for 48 months post-partum if assigned to
the DTG arm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified