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NCT00001025 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Patients Who Have Not Had Success With Zidovudine
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 18
- Study locations
NCT00001025 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 120 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (73% lower). The trial reports 18 study locations across 9 states.
The verdict
NCT00001025, 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
- 120 participants
- Enrollment target
- 18
- Study locations
Study Summary
To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral load (as determined by plasma viremia and quantitative endpoint dilution). To determine the relationship between viral load and susceptibility during different antiretroviral therapy strategies. To correlate measures of viral load and short term clinical and laboratory markers (such as weight, CD4 count, p24 antigenemia, and beta2 microglobulin) on the different therapy arms. High-grade resistance to AZT has been detected in HIV isolates from approximately 25 percent of individuals with AIDS who received AZT for at least 1 year. To elucidate the clinical significance of in vitro AZT resistance, it is necessary to distinguish between clinical failure caused by AZT resistance and clinical decompensation caused by other factors.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Didanosine
Study Locations (18)
Illinois
- Children's Mem Hosp Family Cln / Northwestern Univ Med Schl - Chicago
- Northwestern Univ Med School - Chicago
- Cook County Hosp - Chicago
- Rush Presbyterian - Saint Luke's Med Ctr - Chicago
New York
- SUNY / Health Sciences Ctr at Brooklyn - Brooklyn
- SUNY / Erie County Med Ctr at Buffalo - Buffalo
- Univ of Rochester Medical Center - Rochester
- SUNY / State Univ of New York - Syracuse
California
- San Francisco Gen Hosp - San Francisco
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium - San Jose
- San Mateo AIDS Program / Stanford Univ - Stanford
Colorado
- Kaiser Permanente Franklin Med Ctr - Denver
- Univ of Colorado Health Sciences Ctr - Denver
Alabama
- Univ of Alabama at Birmingham - Birmingham
Massachusetts
- Baystate Med Ctr of Springfield - Springfield
Minnesota
- Univ of Minnesota - Minneapolis
Nebraska
- Univ of Nebraska Med Ctr - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Est. Completion | 1995-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001025
The ClinicalTrials.gov registry entry for NCT00001025 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 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 (73% 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Zidovudine is the first listed.
NCT00001025 reports 18 study locations spanning 9 distinct geographic areas - top geographies include Illinois, New York, California.
Frequently Asked Questions
What is clinical trial NCT00001025 about?
NCT00001025 is a clinical study titled "Evaluation of Patients Who Have Not Had Success With Zidovudine". To determine the relationship of viral susceptibility to zidovudine (AZT) and baseline viral load (as determined by plasma viremia and quantitative endpoint dilution). To determine the relationship between viral load and susceptibility during different antiretroviral therapy strategies. To correlate...
What is the current status of trial NCT00001025?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. Estimated completion is 1995-05.
What conditions does trial NCT00001025 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00001025?
The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00001025?
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 NCT00001025 being conducted?
This trial has 18 study locations across Alabama, California, Colorado, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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