Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose is to evaluate the efficacy of maternal and infant perinatal antiretroviral prophylaxis intensification for the prevention of mother-to-child intrapartum transmission of HIV-1 in women receiving less than 8 weeks of antiretroviral prophylaxis during pregnancy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherche pour le Developpement
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Harvard School of Public Health; Harvard School of Public Health (HSPH)
• Treatments: Lamivudine; Nevirapine; Zidovudine

Criteria

Eligibility. Pregnant women presenting at the prenatal clinics will be eligible if they are confirmed HIV-infected, intend to deliver and bring their infant to a study site for postnatal care for at least 6 months; at least 18 years old; and have given written informed consent to participate in the study, regardless of their CD4 cell count.

Maternal inclusion criteria:

• Evidence of HIV infection, as documented by two serology tests obtained at two different dates;

• All HIV infected pregnant women will be enrolled, either in the intervention arm or an observational study group.

• Women more than 30 weeks gestational age at start of antiretroviral treatment will be eligible for the intervention. They will actually receive the study intervention if they present in labor after less than 8 weeks of treatment duration;

• Women with no ANC will receive standard care and will be enrolled in an observational study group(and their infant will receive standard of care perinatal antiretroviral intensification)

• Women with less than 30 weeks gestational age at start of treatment will receive standard care and will also be enrolled in the Observational Reference group;

• Agreement not to breastfeed;

• Consent to participate and to be followed for the duration of the study

Exclusion Criteria:

• Evidence of pre-existing fetal anomalies incompatible with life;

• Concurrent participation to any other clinical trial without prior agreement of the two study teams