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This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell counts at high risk of malaria. The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria.
The study site will be the Tororo district hospital campus situated in Eastern Uganda, an area of high malaria transmission. Using convenience sampling, we will enroll 500 HIV-infected pregnant women from the Tororo community. Eligible women between 12-28 weeks gestation will be randomized at enrollment to receive either a PI- based or an NNRTI-based ART regimen after stratification by gravidity (G1 versus G2+) and gestational age (<24 weeks versus ≥ 24 weeks at enrollment).
Treatment group A will receive Zidovudine 300mg + Lamivudine 150mg + Efavirenz 600mg. Treatment group B will receive Zidovudine 300mg + Lamivudine 150mg + Lopinavir/ritonavir 200mg/50mg.
At enrollment, all study participants will receive a long lasting ITN as part of a basic care package including a safe water vessel, multivitamins and condoms, as per current standard of care for HIV-infected pregnant women in Uganda, if they have not already received these interventions from the referral site. Two ITNs will be provided for each mother-infant pair. Participants will receive all routine and acute medical care at a designated study clinic open 7 days a week from 8 a.m. to 5 p.m. If medical care is needed after hours, they will be instructed to bring them to Tororo District Hospital premises (where the study clinic is located) and request that the study physician on-call be contacted. They will be followed up from the time of enrollment during pregnancy and through the cessation of breastfeeding; seen monthly for routine assessments and laboratory evaluations. Following delivery, the infants of enrolled women will be followed until 6 weeks following the cessation of breastfeeding but not beyond 24 weeks of life. Study participants will be followed closely for adverse events potentially due to study drugs and for malaria and HIV treatment outcomes. During the follow-up period, all patients presenting to the clinic with a new episode of fever will undergo standard evaluation (history, physical examination and Giemsa-stained blood smear) for the diagnosis of malaria.
Women will receive the study treatment from the time of study entry and randomization (12-28 weeks gestation) until 24 weeks postpartum or until the cessation of breastfeeding if that occurs prior to 24 weeks postpartum. If a subject experiences a toxicity endpoint, ART will be changed to provide antiviral activity prior to delivery. All women will receive daily oral trimethoprim/sulfamethoxazole (TS) per Ugandan MOH guidelines.
Per Ugandan MOH guidelines, all newborns will receive zidovudine syrup 4mg/kg PO BID starting within 12 hours after birth for 7 days, daily oral TS from 6 weeks of life until 6 weeks following the cessation of breastfeeding, and their mothers will be instructed on ITN use for their infants. Breastfeeding will be encouraged until 24 weeks postpartum which is the standard of care in Uganda. Furthermore, if an infant is found to be HIV-infected, Uganda MOH guidelines recommend the continuation of breastfeeding and daily TS beyond these 24 weeks.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Lopinavir/ritonavir, Efavirenz, Zidovudine, Lamivudine
Tororo District Hospital
University of California, San Francisco
Published on BioPortfolio: 2014-08-27T03:18:46-0400
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