Study Title:
IMPAACT 2010 Phase III Study of virologic efficacy and safety of Dolutegravir containing versus efavirenz-containing Antiretroviral therapy Regimens in HIV-1-Infected Pregnant Women and theire Infants Versin 1.0, 1 December 2016
Sponsor Name: National insitute of Allergy and infectious diseases and NICHD
Application Number: TFDA0017/CTR/0001, Date Received: 17/01/2017
Principal Investigator: Dr James Samwel Ngocho
Intervention Medicinal Product Status of IMP
Dolutegravir Registered
Primary Disease: HIV Infection
Trial Site: KCMC-Duke University AIDS Collaboration, P.O.Box 3010 MOSHI
Start / Approval Date: 07/05/2017, Status / Approval Remark: Approved
Primary Purpose: To compare the DTG-containing arms (Arms 1 and 2) to the EFV-containing arm (Arm 3) with respect to maternal viral suppression at delivery; to compute all pairwise regimen comparisons for a composite adverse pregnancy outcome (spontaneous abortion, fetal death, preterm delivery, or small for gestational age); and to compute all pairwise regimen comparisons for maternal and infant grade 3 or higher adverse events through 50 weeks postpartum.
Study Phase: Phase III
Study Type: Interventional
Expected Completion Date: 07/04/2020
Target Sample Size: 639 pair
Recruitment Status: Recruiting
Outcome: HIV-1 RNA <200 copies/mL at delivery (up to 14 days postpartum), using real-time test results obtained at site laboratories