Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their … (NCT00006396) | Clinical Trial Compass
CompletedPhase 3
Effectiveness of AZT and Nevirapine in Preventing HIV Transmission From Ugandan Mothers to Their Newborns
United States1,500 participants
Plain-language summary
The purpose of this study is to see if nevirapine (NVP) or zidovudine (AZT), given to mothers during labor and delivery and to their babies during the first week of life, can reduce the rate of mothers passing HIV to their babies.
About 25 percent of HIV-infected mothers pass HIV infection to their babies during labor and delivery. There is an urgent need to find a simpler way to prevent mother-to-infant transmission during labor and delivery. The proposed NVP schedule is simpler and possibly could be used in Uganda.
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:
* Have been pregnant for more than 32 weeks and are at least 18 years of age.
* Are HIV-positive.
* Reside within 15 km of Mulago Hospital, the study site.
* Infants may be eligible for this study if they:
* Are born to mothers enrolled in the study.
* Have consent of the mother/guardian and, if available, the father.
Exclusion Criteria
Mothers will not be eligible for this study if they:
* Have a serious infection or illness other than HIV.
* Currently take any anti-HIV drugs.
* Participate during this pregnancy in another treatment vaccine perinatal trial.
* Received NVP or AZT within the last 6 months.
* Are allergic to any benzodiazepine.
* Abuse alcohol or other drugs.
* Have high blood pressure that is not controlled.
* Have received any anticoagulants, benzodiazepines other than the study drug, or magnesium sulfate within 2 weeks before being assigned to a study group or delivery.
* Infants will not be eligible for this study if:
* Their mother is excluded prior to being assigned to a study group.
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 IDNCT00006396
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)