A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if a combination anti-HIV drug treatment regimen of indinavir plus lamivudine (3TC) plus zidovudine (ZDV) is effective in treating HIV and in reducing the chances of passing HIV from mother to child. This study will also examine if this combination is well tolerated by HIV-positive pregnant women and if a combination of 3TC plus ZDV is safe for newborns.

Previous studies in adults and children have shown that indinavir plus 3TC plus ZDV can reduce the amount of HIV in the blood. Most HIV-positive pregnant women usually take ZDV to treat HIV and to reduce the chances of giving HIV to their babies. The combination of drugs in this study may be more effective than ZDV alone.

• 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: Indinavir; Lamivudine; Zidovudine

Criteria

Inclusion Criteria

Women may be eligible for this study if they:

• Are HIV-positive.

• Have been pregnant for 14-28 weeks (are in your 1st or 2nd trimester).

• Have a normal ultrasound exam when they are screened for the study.

• Are able to drink 6 glasses of water a day throughout the study.

• Are at least 13 years old (need consent of parent or guardian if under 18).

Exclusion Criteria

Women will not be eligible for this study if they:

• Cannot take 3TC or ZDV.

• Have an active opportunistic (HIV-associated) or bacterial infection at study entry.

• Have chronic diarrhea.

• Have epilepsy or cancer.

• Are pregnant with more than 2 children (triplets, etc.)

• Have risk factors for premature birth, or other problems with their pregnancy.

• Have any immediate life-threatening illness.

• Have severe anemia or other illness for which they require blood products.

• Have a history of chronic liver or kidney disease.

• Plan to breast-feed.