A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3… (NCT00000878) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
United States, Puerto Rico26 participants
Plain-language summary
The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T and 3TC, given in combination to HIV-positive pregnant women and their infants.
Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV and reduce the chances of giving HIV to their babies. It recently has been shown that a combination of drugs may be more effective than ZDV alone. This study tests the effectiveness of combinations of ZDV, d4T, and 3TC.
Who can participate
Age range
13 Years
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
Women may be eligible for this study if they:
* Are HIV-positive.
* Are at least 13 years old (need consent of parent or guardian if under 18).
* Are unable to or refuse to take ZDV or the woman's doctor says that she should take d4T.
* Are 14 to 34 weeks pregnant.
Exclusion Criteria
Women will not be eligible for this study if they:
* Have a history of peripheral neuropathy.
* Have an active opportunistic infection and/or serious bacterial infection within 14 days of study entry.
* Have severe diarrhea.
* Are allergic to d4T or 3TC.
* Use illicit drugs or abuse alcohol.
* Are taking anti-HIV drugs other than study medications.
* Are planning to breast-feed.
* Are having a problem pregnancy (baby is not developing correctly or will not survive birth) or have had pregnancy complications in the past.
* Babies will not be eligible for this study if they:
* Are unable to take medications by mouth for more than 72 hours.
* Have severe birth defects or other life-threatening conditions.
* Are underweight (less than 2 kg).
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 IDNCT00000878
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)