Status:
COMPLETED
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
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:
FEMALE
13+ years
Phase:
PHASE1
Brief 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 cha...
Detailed Description
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 re...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 2003
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00000944
End Date
March 1 2003
Last Update
October 29 2021
Active Locations (4)
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1
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 94143
2
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
3
Jacobi Med. Ctr.
The Bronx, New York, United States, 10461
4
Montefiore Med. Ctr. - AECOM
The Bronx, New York, United States