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
A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Indinavir Co-Administered With Lamivudine (3TC) and Zidovudine (ZDV) in HIV-1-Infected Pregnant Women During Gestation and Post Partum, and in Their Infants Post Maternal Dosing
3 other identifiers
interventional
24
1 country
4
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
UCSF Pediatric AIDS CRS
San Francisco, California, 94143, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 02115, United States
Jacobi Med. Ctr.
The Bronx, New York, 10461, United States
Montefiore Med. Ctr. - AECOM
The Bronx, New York, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Diana Wara
- STUDY CHAIR
Yvonne Bryson
- STUDY CHAIR
Ruth Tuomala
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- PREVENTION
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
March 1, 2003
Last Updated
October 29, 2021
Record last verified: 2021-10