The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months
Public ClinicalTrials.gov record NCT00006279. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II Study to Assess the Safety and Plasma Concentrations of Nevirapine Given Daily, Twice a Week or Weekly as Prophylaxis in Breastfeeding Infants From Birth to 6 Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to see if it is safe to give nevirapine (NVP) to breast-feeding babies from birth to the age of 6 months and to determine what dose of NVP should be given. Breast-feeding has been shown to be very important for the physical and mental health of infants. This is especially true during the first 6 months of life. However, an HIV-positive mother can pass the virus on to her baby by breast-feeding. Because of this risk, HIV-positive mothers are encouraged to formula-feed, not breast-feed, their babies. In developing countries, however, some women cannot afford to formula-feed. If they do formula-feed, these women risk exposing their HIV status. These women have great need for methods that can lower the chance that they will pass HIV on to their babies. This study will test NVP as a way of doing this.
Study identification
- NCT ID
- NCT00006279
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Day and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Apr 30, 2005
- Last update posted
- Oct 31, 2021
Ends 2005
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kathy George | Durham | North Carolina | 27713 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00006279, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 31, 2021 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00006279 live on ClinicalTrials.gov.