Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients With No Symptoms of the Disease
Public ClinicalTrials.gov record NCT00001045. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blinded, Randomized Trial Comparing Zidovudine (AZT) Versus AZT Plus Didanosine (ddI) Versus AZT Plus ddI Plus Nevirapine in Asymptomatic Patients on AZT Monotherapy Who Develop a Mutation at Codon 215 of HIV Reverse Transcriptase in Serum/Plasma Viral RNA
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00001045
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Oct 1998 (Actual)
- Last update posted
- Nov 4, 2021
Ends 1998
United States locations
- U.S. sites
- 57
- U.S. states
- 17
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA CARE Ctr | Los Angeles | California | 90095 | — |
| Stanford at Kaiser / Kaiser Permanente Med Ctr | San Francisco | California | 94115 | — |
| Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium | San Jose | California | 951282699 | — |
| San Mateo AIDS Program / Stanford Univ | Stanford | California | 943055107 | — |
| Stanford Univ Med Ctr | Stanford | California | 943055107 | — |
| Harbor UCLA Med Ctr | Torrance | California | 90502 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Georgetown Univ Med Ctr | Washington D.C. | District of Columbia | 20007 | — |
| Children's Hosp of Washington DC | Washington D.C. | District of Columbia | 200102916 | — |
| George Washington Univ / Hershey Med Ctr | Washington D.C. | District of Columbia | 20037 | — |
| Walter Reed Army Med Ctr | Washington D.C. | District of Columbia | 20307 | — |
| Emory Univ Hosp / Pediatrics | Atlanta | Georgia | 30306 | — |
| Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr | Atlanta | Georgia | 303652225 | — |
| Queens Med Ctr | Honolulu | Hawaii | 96816 | — |
| Univ of Hawaii | Honolulu | Hawaii | 96816 | — |
| Indiana Univ Hosp | Indianapolis | Indiana | 462025250 | — |
| Univ of Iowa Hosp and Clinic | Iowa City | Iowa | 52242 | — |
| State of MD Div of Corrections / Johns Hopkins Univ Hosp | Baltimore | Maryland | 212052196 | — |
| Johns Hopkins Hosp | Baltimore | Maryland | 21287 | — |
| Natl Naval Med Ctr | Bethesda | Maryland | 208995000 | — |
| Fitzsimmons Army Med Ctr | Rockville | Maryland | 20850 | — |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | — |
| Hennepin County Med Clinic | Minneapolis | Minnesota | 55415 | — |
| Univ of Minnesota | Minneapolis | Minnesota | 55455 | — |
| St Paul Ramsey Med Ctr | Saint Paul | Minnesota | 55101 | — |
| Univ of Nebraska Med Ctr | Omaha | Nebraska | 681985130 | — |
| Adirondack Med Ctr at Saranac Lake | Albany | New York | 122083479 | — |
| Albany Med College / Division of HIV Medicine A158 | Albany | New York | 122083479 | — |
| Mid - Hudson Care Ctr | Albany | New York | 122083479 | — |
| SUNY / Erie County Med Ctr at Buffalo | Buffalo | New York | 14215 | — |
| Bellevue Hosp / New York Univ Med Ctr | New York | New York | 10016 | — |
| Columbia Presbyterian Med Ctr | New York | New York | 100323784 | — |
| Harlem Hosp Ctr | New York | New York | 10037 | — |
| Univ of Rochester Medical Center | Rochester | New York | 14642 | — |
| SUNY / State Univ of New York | Syracuse | New York | 13210 | — |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | The Bronx | New York | 10461 | — |
| Comprehensive Health Care Ctr / Bronx Municipal Hosp | The Bronx | New York | 10461 | — |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | The Bronx | New York | 10461 | — |
| Jack Weiler Hosp / Bronx Municipal Hosp | The Bronx | New York | 10465 | — |
| Montefiore Med Ctr / Bronx Municipal Hosp | The Bronx | New York | 10467 | — |
| Montefiore Med Ctr Adolescent AIDS Program | The Bronx | New York | 10467 | — |
| North Central Bronx Hosp / Bronx Municipal Hosp | The Bronx | New York | 10467 | — |
| Univ of North Carolina | Chapel Hill | North Carolina | 275997215 | — |
| Carolinas Med Ctr | Charlotte | North Carolina | 28203 | — |
| Wake County Dept of Health | Raleigh | North Carolina | 27610 | — |
| Case Western Reserve Univ | Cleveland | Ohio | 44106 | — |
| MetroHealth Med Ctr | Cleveland | Ohio | 441091998 | — |
| Ohio State Univ Hosp Clinic | Columbus | Ohio | 432101228 | — |
| Med College of Ohio | Toledo | Ohio | 43699 | — |
| Milton S Hershey Med Ctr | Hershey | Pennsylvania | 170330850 | — |
| Univ of Pennsylvania at Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson Univ Hosp | Philadelphia | Pennsylvania | 191075098 | — |
| Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr | Knoxville | Tennessee | 37920 | — |
| Vanderbilt Univ Med Ctr | Nashville | Tennessee | 37203 | — |
| Univ of Texas Galveston | Galveston | Texas | 775550435 | — |
| Wilford Hall Med Ctr | Lackland Air Force Base | Texas | 782365300 | — |
| Brooke Army Med Ctr | San Antonio | Texas | 78284 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001045, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 4, 2021 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00001045 live on ClinicalTrials.gov.