Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
|ClinicalTrials.gov Identifier: NCT00074399|
Recruitment Status : Completed
First Posted : December 15, 2003
Last Update Posted : August 7, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Nevirapine Drug: Nevirapine placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||775 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
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
- Infant HIV infection status [ Time Frame: At Months 6 and 12 ]
- Infant mortality rate [ Time Frame: Throughout study ]
- Infant morbidity rate [ Time Frame: Throughout study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00074399
|Tikur Anbessa Hospital|
|Addis Ababa, Ethiopia|