Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of HIV Infections and Pregnancy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00000878 record still lists
NCT00000878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% 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.
NCT00000878 names 20 study sites across 12 states, led by 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.
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 NCT00000878's enrollment target sits among peer trials
26 457th of 542 higher than 83 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
CAR-T Cells for HIV Infection
RECRUITING · Phase 1
-
A Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV
RECRUITING · Phase 1
-
Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Adult Participants Who Previously Participated in HVTN 706
RECRUITING · Phase 1
-
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
RECRUITING · Phase 1
-
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
RECRUITING · Phase 1
-
First Time in Human Study of Long Acting VH4524184 Formulations
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)