Status:
COMPLETED
Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers
Lead Sponsor:
Institut de Recherche pour le Developpement
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 rec...
Detailed Description
Design: a multicenter, phase III, single-arm trial. Perinatal antiretroviral intensification (study treatment) is defined as the addition to the standard of care\* for mothers and infants of: * Moth...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
379 Patients enrolled
Trial Details
Trial ID
NCT01511237
Start Date
December 1 2011
End Date
March 1 2017
Last Update
October 22 2021
Active Locations (36)
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1
Prapokklao Hospital
Chanthaburi, Changwat Chanthaburi, Thailand, 22000
2
Mae Chan Hospital
Mae Chan, Changwat Chiang Rai, Thailand, 57110
3
Phan Hospital
Phan, Changwat Chiang Rai, Thailand, 57120
4
Banglamung Hospital
Bang Lamung, Changwat Chon Buri, Thailand, 20150