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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 recipients of ZDV. d4T is a good candidate drug. It is a thymidine nucleoside analogue that inhibits replication of HIV at concentrations similar to those of ZDV which have anti-HIV activity. The demonstrated safety profile of d4T, the ease of administration, and, most importantly, preliminary efficacy data, especially in combination with 3TC, make this an excellent candidate combination for a Ph...

Gender

ALL

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).