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NCT00000944 · ClinicalTrials.gov registry record · Phase 1
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 1 study of HIV Infections and Pregnancy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 4
- Study locations
NCT00000944: Completed Phase 1 study of HIV Infections and Pregnancy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000944 is a Phase 1 study of HIV Infections and Pregnancy that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000944, a Phase 1 study of HIV Infections and Pregnancy, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Indinavir sulfate
Study Locations (4)
New York
- Jacobi Med. Ctr. - The Bronx
- Montefiore Med. Ctr. - AECOM - The Bronx
California
- UCSF Pediatric AIDS CRS - San Francisco
Massachusetts
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Est. Completion | 2003-03 |
| Phase | Phase 1 |
What the finished NCT00000944 record still lists
NCT00000944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Zidovudine is the first listed.
NCT00000944 reports a single indexed study location in New York, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00000944 about?
NCT00000944 is a clinical study titled "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". 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 t...
What is the current status of trial NCT00000944?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. Estimated completion is 2003-03.
What conditions does trial NCT00000944 study?
This clinical trial studies the following conditions: HIV Infections, Pregnancy.
What interventions are being tested in trial NCT00000944?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Indinavir sulfate (DRUG).
Who is sponsoring clinical trial NCT00000944?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00000944 being conducted?
This trial has 4 study locations across California, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00000944's enrollment target sits among peer trials
24 470th of 542 higher than 64 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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