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

Hawassa University0 个研究点目标入组 1,830 人开始时间: 2019年9月14日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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.

•- 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.

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