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NCT00000878 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) 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
- 26
- Enrollment target
- 20
- Study locations
NCT00000878 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 26 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT00000878, 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
- 26 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T and 3TC, given in combination to HIV-positive pregnant women and their infants. Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV and reduce the chances of giving HIV to their babies. It recently has been shown that a combination of drugs may be more effective than ZDV alone. This study tests the effectiveness of combinations of ZDV, d4T, and 3TC.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Stavudine
Study Locations (20)
California
- Los Angeles County - USC Med Ctr - Los Angeles
- UCLA Med Ctr / Pediatric - Los Angeles
- Harbor - UCLA Med Ctr / UCLA School of Medicine - Los Angeles
Florida
- Univ of Florida Health Science Ctr / Pediatrics - Jacksonville
- Univ of Miami / Jackson Memorial Hosp - Miami
- Univ of Miami (Pediatric) - Miami
Massachusetts
- Children's Hosp of Boston - Boston
- Brigham and Women's Hosp - Boston
New York
- Children's Hosp at Albany Med Ctr - Albany
- SUNY Health Sciences Ctr at Syracuse / Pediatrics - Syracuse
Tennessee
- Regional Med Ctr at Memphis - Memphis
- Saint Jude Children's Research Hosp of Memphis - Memphis
Other
- Univ of Puerto Rico / Univ Children's Hosp AIDS - San Juan
- San Juan City Hosp - San Juan
District of Columbia
- Howard Univ Hosp - Washington D.C.
Illinois
- Univ of Chicago Children's Hosp - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Est. Completion | 2001-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000878
The ClinicalTrials.gov registry entry for NCT00000878 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
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.
NCT00000878 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00000878 about?
NCT00000878 is a clinical study titled "A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants". The purpose of this study is to evaluate the safety and tolerance of 2 anti-HIV drugs, d4T and 3TC, given in combination to HIV-positive pregnant women and their infants. Most HIV-positive pregnant women usually take the anti-HIV drug zidovudine (ZDV) to treat HIV and reduce the chances of giving H...
What is the current status of trial NCT00000878?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. Estimated completion is 2001-10.
What conditions does trial NCT00000878 study?
This clinical trial studies the following conditions: HIV Infections, Pregnancy.
What interventions are being tested in trial NCT00000878?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Stavudine (DRUG).
Who is sponsoring clinical trial NCT00000878?
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 NCT00000878 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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