Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.
Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
|Official Title:||Nevirapine (NVP) Use to Prevent Maternal-Infant HIV Transmission: A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant|
- Infant HIV infection status [ Time Frame: At Months 6 and 12 ] [ Designated as safety issue: No ]
- Infant mortality rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Infant morbidity rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2001|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Participants will receive nevirapine for 6 weeks
Tablet taken orally daily. Dosage depends on age and body surface area
Placebo Comparator: 2
Participants will receive nevirapine placebo for 6 weeks
Drug: Nevirapine placebo
Placebo tablet taken orally daily
The use of antiretroviral therapy during late pregnancy, intrapartum, and immediately postpartum prevents a high proportion of vertical transmission. Potential means of decreasing HIV transmission through breastfeeding, along with the risks and benefits of early weaning, need to be further evaluated. The potential impact of early weaning interventions on the breastfeeding habits of the HIV uninfected population needs to be considered as well. This study seeks to identify a way to make breastfeeding safe for HIV infected women who choose to breastfeed.
A single dose of NVP given to infants of HIV infected mothers appears to provide some protection against vertical transmission. NVP's long half-life allows simple dosing, making it more feasible and affordable to implement in a developing country. This study will determine whether extending the NVP dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding.
|Tikur Anbessa Hospital|
|Addis Ababa, Ethiopia|