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NCT00000671 · ClinicalTrials.gov registry record · Phase 2
A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 750
- Enrollment target
- 20
- Study locations
NCT00000671: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000671 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 750 participants, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (69% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000671, 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
- 750 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS or advanced AIDS-related complex (ARC) who have tolerated AZT therapy for 12 months or longer. Per amendment, asymptomatic patients with CD4 counts less than 200 cells/mm3 are eligible. AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low frequency of drug administration.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Didanosine
Study Locations (20)
California
- Children's Hosp of Los Angeles/UCLA Med Ctr - Los Angeles
- Los Angeles County - USC Med Ctr - Los Angeles
- Cedars Sinai / UCLA Med Ctr - Los Angeles
- UCLA CARE Ctr - Los Angeles
- Harbor - UCLA Med Ctr / UCLA School of Medicine - Los Angeles
- Palo Alto Veterans Adm Med Ctr / Stanford Univ - Palo Alto
- Univ of California / San Diego Treatment Ctr - San Diego
- San Francisco AIDS Clinic / San Francisco Gen Hosp - San Francisco
- Stanford at Kaiser / Kaiser Permanente Med Ctr - San Francisco
- Stanford Univ School of Medicine - Stanford
- Olive View Med Ctr - Sylmar
- Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr - Sylmar
- Harbor UCLA Med Ctr - Torrance
Colorado
- Mountain States Regional Hemophilia Ctr / Univ of Colorado - Denver
- Univ of Colorado Health Sciences Ctr - Denver
Florida
- G E Morey Jr - Fort Lauderdale
- Univ of Miami School of Medicine - Miami
Illinois
- Northwestern Univ Med School - Chicago
- Rush Presbyterian - Saint Luke's Med Ctr - Chicago
District of Columbia
- George Washington Univ Med Ctr - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Phase | Phase 2 |
What the finished NCT00000671 record still lists
NCT00000671 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, above the 444-participant average among 542 other HIV Infections trials with a reported enrollment target (69% higher).
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.
NCT00000671 names 20 study sites across 5 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT00000671 about?
NCT00000671 is a clinical study titled "A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment". To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS or advanced AIDS-related complex (ARC) who have tolerated AZT therapy for 12 months or longer. Per amendment, asymptomatic patients with CD4 counts less than 200 cells/mm3 are eligible. AZT is e...
What is the current status of trial NCT00000671?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 750 participants.
What conditions does trial NCT00000671 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000671?
The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00000671?
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 NCT00000671 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. 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 NCT00000671's enrollment target sits among peer trials
750 41st of 542 higher than 501 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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