A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

• Status: Completed
• Trial end date: 2001-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Lamivudine; Stavudine; Zidovudine

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).