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

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

Keywords

ClinConnect Summary

Despite the dramatic reduction of perinatal HIV transmission following the administration of ZDV to mothers and infants, new, more effective strategies are needed. An increasing number of women may require combination antiretroviral therapy for their own disease because they may be resistant to ZDV, may have high viral loads, or may have previously transmitted HIV to an infant while on ZDV monotherapy. The initiation of triple combination therapy, including a protease inhibitor indinavir, during gestation may be the most effective in reducing maternal virus load prior to delivery, thereby p...

Gender

FEMALE

Eligibility 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.

Trial Officials