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NCT00000789 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT00000789: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000789 is a Phase 2 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 230 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000789, a Phase 2 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
Study Summary
PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children. SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs. At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Stavudine
Study Locations (20)
California
- Long Beach Memorial Med. Ctr., Miller Children's Hosp. - Long Beach
- Usc La Nichd Crs - Los Angeles
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS - Los Angeles
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. - Oakland
- UCSD Maternal, Child, and Adolescent HIV CRS - San Diego
- UCSF Pediatric AIDS CRS - San Francisco
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases - Torrance
Illinois
- Cook County Hosp. - Chicago
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. - Chicago
- Chicago Children's CRS - Chicago
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease - Chicago
Connecticut
- Univ. of Connecticut Health Ctr., Dept. of Ped. - Farmington
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease - New Haven
District of Columbia
- Children's National Med. Ctr., ACTU - Washington D.C.
- Howard Univ. Washington DC NICHD CRS - Washington D.C.
Florida
- Univ. of Florida Jacksonville NICHD CRS - Jacksonville
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS - Miami
Colorado
- Univ. of Colorado Denver NICHD CRS - Aurora
Georgia
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases - Atlanta
Louisiana
- Tulane/LSU Maternal/Child CRS - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Est. Completion | 1998-07 |
| Phase | Phase 2 |
What the finished NCT00000789 record still lists
NCT00000789 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (48% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.
NCT00000789 names 20 study sites across 8 states, led by California, Illinois, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00000789 about?
NCT00000789 is a clinical study titled "A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection". PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children. SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both dru...
What is the current status of trial NCT00000789?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 230 participants. Estimated completion is 1998-07.
What conditions does trial NCT00000789 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000789?
The interventions under investigation include: Zidovudine (DRUG), Stavudine (DRUG).
Who is sponsoring clinical trial NCT00000789?
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 NCT00000789 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00000789's enrollment target sits among peer trials
230 154th of 542 higher than 388 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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