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NCT00001045 · ClinicalTrials.gov registry record · Phase 2
Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT00001045 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 300 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00001045, 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
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
To validate that the alteration of codon 215 of reverse transcriptase in plasma virus precedes the increase in viral burden as measured in the peripheral blood and the decline in CD4 count that have been observed in association with clinical failure on zidovudine (AZT). To determine whether alternative regimens of antiretroviral agents alter the course of viral burden as measured in the peripheral blood and CD4 changes in patients with HIV infection. To obtain further data on the safety and immunologic and virologic response to AZT/didanosine/nevirapine. Of the HIV-1 mutations reported to be associated with zidovudine resistance, the mutation at codon 215 of the reverse transcriptase gene is the most commonly occurring and has the greatest impact on susceptibility. When this mutation appears, a change in drugs may prevent further immunologic and virologic deterioration.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Didanosine
- DRUG Nevirapine
Study Locations (20)
California
- UCLA CARE Ctr - Los Angeles
- Stanford at Kaiser / Kaiser Permanente Med Ctr - San Francisco
- Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium - San Jose
- San Mateo AIDS Program / Stanford Univ - Stanford
- Stanford Univ Med Ctr - Stanford
- Harbor UCLA Med Ctr - Torrance
District of Columbia
- Georgetown Univ Med Ctr - Washington D.C.
- Children's Hosp of Washington DC - Washington D.C.
- George Washington Univ / Hershey Med Ctr - Washington D.C.
- Walter Reed Army Med Ctr - Washington D.C.
Maryland
- State of MD Div of Corrections / Johns Hopkins Univ Hosp - Baltimore
- Johns Hopkins Hosp - Baltimore
- Natl Naval Med Ctr - Bethesda
Georgia
- Emory Univ Hosp / Pediatrics - Atlanta
- Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr - Atlanta
Hawaii
- Queens Med Ctr - Honolulu
- Univ of Hawaii - Honolulu
Colorado
- Univ of Colorado Health Sciences Ctr - Denver
Indiana
- Indiana Univ Hosp - Indianapolis
Iowa
- Univ of Iowa Hosp and Clinic - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Est. Completion | 1998-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001045
The ClinicalTrials.gov registry entry for NCT00001045 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (33% 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 3 interventions - of which Zidovudine is the first listed.
NCT00001045 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT00001045 about?
NCT00001045 is a clinical study titled "Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease". To validate that the alteration of codon 215 of reverse transcriptase in plasma virus precedes the increase in viral burden as measured in the peripheral blood and the decline in CD4 count that have been observed in association with clinical failure on zidovudine (AZT). To determine whether alternat...
What is the current status of trial NCT00001045?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants. Estimated completion is 1998-10.
What conditions does trial NCT00001045 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00001045?
The interventions under investigation include: Zidovudine (DRUG), Didanosine (DRUG), Nevirapine (DRUG).
Who is sponsoring clinical trial NCT00001045?
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 NCT00001045 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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