The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months (NCT00006279) | Clinical Trial Compass
CompletedPhase 1
The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months
United States75 participants
Plain-language summary
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.
Who can participate
Age range
1 Day
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Mothers may be eligible for this study if they:
* Receive prenatal care at King Edward VIII Hospital, Durban, or St. Mary's Hospital, Marianhill, South Africa; or polyclinics in Chitungwiza District, Zimbabwe.
* Are pregnant for at least 30 weeks before giving birth.
* Are at least 18 years of age.
* Are HIV-positive by 2 ELISA tests.
* Have no serious current or previous problems in pregnancy (e.g., seizures).
* Have a fixed home and/or work address.
* Plan to deliver the baby at a hospital or clinic where the study is based.
* Plan to breast-feed their babies.
* Infants may be eligible for this study if they:
* Are born to women participating in this study.
* Weigh at least 2.5 kg at birth.
* Begin breast-feeding by 48 hours.
Exclusion Criteria
Mothers will not be eligible for this study if they:
* Have AIDS or any other serious illness.
* Are using illegal drugs or have been using alcohol for a long time.
* Are sensitive to NVP.
* Have taken any nonnucleoside reverse transcriptase inhibitors in the past.
* Are using rifampin, rifabutin, ketoconazole, macrolides, or cimetidine.
* Infants will not be eligible for this study if they:
* Have jaundice (yellowing of the skin and whites of eyes) that requires a blood transfusion.
* Have any serious or life-threatening condition(s).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00006279
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)