Status:
COMPLETED
A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Pregnancy
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief 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 w...
Detailed Description
New antiretroviral agents or combinations are sought that are as efficacious as ZDV and that would be effective in reducing the rate of vertical transmission of HIV in women who have been long-term re...
Eligibility Criteria
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).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 2001
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00000878
End Date
October 1 2001
Last Update
October 29 2021
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
2
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
3
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
4
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060