HIV Infections
Conditions
Keywords
HIV, MTCT, Infants, africa, HIV Seronegativity
Brief summary
The purpose of this study is to determine if extended antiretroviral regimens given to the infant during the first 14 weeks of age would decrease breast milk transmission of HIV.
Detailed description
This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT given twice daily for 1 week (comparison regimen). All infants receive the comparison regimen at birth and then randomized at birth to start either one of the two extended regimens after the first week. The extended regimens are nevirapine daily and nevirapine plus AZT daily - both regimens are given up to age 14 weeks.
Interventions
DRUGNevirapine
Oral NVP daily dosage
DRUGAZT
Oral AZT daily
DRUGNVP and AZT
Oral single dose NVP plus oral daily AZT during the first weeks
DRUGNVP
Oral NVP daily to age 14 weeks
DRUGNVP+AZT
Oral NVP daily plus oral AZT daly to age 14 weeks
Sponsors
Centers for Disease Control and Prevention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
No
Inclusion criteria
* Had given birth within the last 24 hours * Ability and willingness to give informed consent for HIV testing and enrollment into the study * Willing to receive HIV results * HIV infected * Planning to deliver or had given birth at the study clinics * Willing to come back for follow-up visits for 2 years postnatally * Resident of Blantyre city or its suburbs
Exclusion criteria
* HIV negative * Women with discordant HIV results * Women who indicate that they will not breastfeed at time of delivery * Inability or unwillingness to follow any of the inclusion requirements * Newborn with life-threatening condition * Women who previously enrolled in this study and have a second pregnancy cannot reenroll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. Rate of HIV infection at 9 months and assess HIV infection rates at 6-8 & 14 weeks, and 6, 12, 18, and 24 months. B.Determine HIV survival rates at ages 6, 12, 18, and 24 months. C. Evaluate safety of oral NVP and ZDV for 14 weeks. | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| To determine overall infant survival rates at 6, 12, 18 and 24 months. | 6,12,18 & 24 months |
Countries
Malawi
Outcome results
None listed