A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood
Public ClinicalTrials.gov record NCT00000916. 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 Phase II, Randomized Study of the Safety and Efficacy of Hydroxyurea in Subjects on Potent Antiretroviral Therapy With Less Than 200 Copies/ml of HIV RNA in the Plasma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study compares the safety and effectiveness of continuing your current anti-HIV medications to that of adding or switching some of your anti-HIV medications. It will follow the effect of these medication changes, including the addition of hydroxyurea (HU), on long-term viral suppression. Other medications which may be added include didanosine (ddI) and/or stavudine (d4T). Patients receiving combination antiretroviral therapy with indinavir (IDV), zidovudine (ZDV)(or d4T) and lamivudine (3TC) show viral suppression for two years or more. Discontinuation of one or two of these drugs results in prompt loss of the viral suppression. Other studies show that addition of HU to some reverse transcriptase inhibitor treatments results in increased antiviral effects. This study will provide further information on the effect of adding HU to a treatment regimen with respect to long-term viral suppression.
Study identification
- NCT ID
- NCT00000916
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 399 participants
Conditions and interventions
Conditions
Interventions
- Indinavir sulfate Drug
- Lamivudine/Zidovudine Drug
- Hydroxyurea Drug
- Lamivudine Drug
- Stavudine Drug
- Zidovudine Drug
- Didanosine Drug
Drug
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
- Aug 2004 (Actual)
- Last update posted
- Oct 29, 2021
Ends 2004
United States locations
- U.S. sites
- 34
- U.S. states
- 19
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35294 | — |
| Stanford CRS | Palo Alto | California | 943055107 | — |
| Ucsd, Avrc Crs | San Diego | California | 921036325 | — |
| San Mateo County AIDS Program | San Mateo | California | 943055107 | — |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | — |
| Univ. of Miami AIDS CRS | Miami | Florida | 331361013 | — |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | — |
| Northwestern University CRS | Chicago | Illinois | 60611 | — |
| Weiss Memorial Hosp. | Chicago | Illinois | 60640 | — |
| Indiana Univ. School of Medicine, Wishard Memorial | Indianapolis | Indiana | 462025250 | — |
| Indiana Univ. School of Medicine, Infectious Disease Research Clinic | Indianapolis | Indiana | 46202 | — |
| Univ. of Iowa Healthcare, Div. of Infectious Diseases | Iowa City | Iowa | 52242 | — |
| Tulane Hemophilia Treatment Ctr. | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Adult AIDS CRS | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital ACTG CRS | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston | Massachusetts | 02215 | — |
| University of Minnesota, ACTU | Minneapolis | Minnesota | 55455 | — |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | 63112 | — |
| Washington U CRS | St Louis | Missouri | — | — |
| Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | Omaha | Nebraska | 681985130 | — |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | 10003 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | — |
| Beth Israel Med. Ctr., ACTU | New York | New York | — | — |
| Univ. of Rochester ACTG CRS | Rochester | New York | 14642 | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 275997215 | — |
| Carolinas HealthCare System, Carolinas Med. Ctr. | Charlotte | North Carolina | 28203 | — |
| Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro | North Carolina | 27401 | — |
| Univ. of Cincinnati CRS | Cincinnati | Ohio | 452670405 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| MetroHealth CRS | Cleveland | Ohio | 441091998 | — |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 432101228 | — |
| Hosp. of the Univ. of Pennsylvania CRS | Philadelphia | Pennsylvania | 19104 | — |
| University of Washington AIDS CRS | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000916, 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 Oct 29, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00000916 live on ClinicalTrials.gov.