CompletedPhase 3

Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding

South Africa, Tanzania, Uganda2,026 participantsStarted 2007-01

Plain-language summary

The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.

Who can participate

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.

Note: As of 08/10/07, the arm assignments for current and new participants have changed. Please see the above description for this trial for more information. Inclusion Criteria for Mothers: * 18 years of age or older * HIV infected * In third trimester of pregnancy, or at most 3 days post-delivery * If baby is not yet born, planning to deliver at a facility where the study is being conducted * Plan to breastfeed Exclusion Criteria for Mothers: * Complications with this pregnancy * Serious medical condition that would interfere with the study (e.g., that would prevent breastfeeding or adherence to the follow-up schedule), as judged by the on-site clinician Inclusion Criteria for Infants: * Born to an HIV infected mother who is eligible for the study * Weighed at least 2000 grams (4.4 lbs) at birth * Blood sample obtained from the infant for HIV-1 DNA PCR, CBC with differential, and ALT * Infants in a multiple birth are eligible only if both/all infants are eligible for the study and assigned to the same study group * Able to breastfeed (e.g., mother and infant alive with no condition apparent that would prevent breastfeeding) Exclusion Criteria for Infants: * HIV DNA PCR positive at birth * ALT of Grade 2 or higher at birth * Hemoglobin, absolute neutrophil count, or platelet count of Grade 3 or higher at birth * Skin rash of Grade 2B (urticaria), Grade 3, or above * Confirmed or suspected clinical hepatitis * Serious illness or condition that would interfere with com…

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.

What they're measuring

HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study

Timeframe: At Month 6

Frequency and Severity of Adverse Reactions Among Participating Infants

Timeframe: 6 weeks through 18 months

Trial details

NCT IDNCT00074412

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-09

Results submitted2013-05-30

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

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.