HIV/AIDS
Conditions
Interventions
Dolutegravir or DTG
EFV400
Sponsors
Hawassa University
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Virological suppression at delivery: Virological suppression will be defined as an undetectable HIV-RNA level (which is < 200 copies/mL) [28]. HIV-1 RNA will be quantified with ANRS generic real-time PCR test. Primary efficacy endpoint will be a comparison of the proportion of participants in each randomly assigned treatment group with a plasma HIV-1 viral < 200 copies per mL at delivery. • Mother to child transmission of HIV: Primary efficacy endpoint for infants born to HIV infected women will be the proportion of infants with no MTCT. Babies will be tested for MTCT of HIV using dried blood spot (DBS) DNA PCR at delivery, 6 weeks and 6 months; and at the age of 12 months using HIV antibody testing. Infant HIV infection will be diagnosed based on available infant diagnosis guidelines in Ethiopia and Uganda. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of participants in each randomly assigned treatment group with plasma HIV-1 viral load less than 200 and 400 copies per mL at delivery, comparisons between treatment groups, time to loss of virological response (plasma HIV-1 viral load =200 copies per mL); mean change from baseline in log10 plasma HIV-1 viral load; mean change in CD4 cell counts; • Type, frequency and severity of adverse events including gestational and drug induced CNS and psychiatric disorder, hepatotoxicity, rash as per EFV and DTG product information that occur during trial and to their potential relations with the drug. CNS includes abnormal dreaming, anxiety, cerebellar disorder and ataxia, dizziness, headache and migraine, vivid dream, insomnia, hallucination, and somnolence. Psychiatric includes depression, fatal suicide, manic reactions, and severe depression. • Mean or median change from baseline in biochemical, haematological, and fasting lipid and glycaemic parameters; rates, rates of opportunistic infections, serious non-AIDS-defining illnesses, and deaths. • Between-group comparisons of change from baseline in health-related quality-of-life scores; depression, anxiety, and stress scores; and self-reported adherence to treatment. • HIV Drug Resistance: Drug resistance testing will be done to determine the proportion of mothers who developed drug resistance in each arm. Genotypic resistance tests will be performed in plasma samples with HIV-1 RNA = 1,000 copies/ml using the consensus technique of AC11 ANRS 2007 v16; possibleresistance will also be considered as resistance (www.hivfrenchresistance.org/). • Maternal and neonatal drug side effects: drug adverse effect monitoring will be done regularly for both mother and fetus/infant including severity assessment using clinical evaluation, obstetric ultrasound and according to DAIDS table [23]. Birth outcomes will be recorded including gestation, birth weight, any congenital anomalies, hospitalization, morbidity, and morta | — |
Countries
Ethiopia, Uganda
Contacts
Public ContactDejene Hailu
Associate Professor
Outcome results
None listed