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NCT00000916 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 399
- Enrollment target
- 20
- Study locations
NCT00000916: Completed Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000916 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 399 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (10% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000916, 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
- 399 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Hydroxyurea
- DRUG Lamivudine
- DRUG Indinavir sulfate
- DRUG Stavudine
- DRUG Lamivudine/Zidovudine
Study Locations (20)
California
- Stanford CRS - Palo Alto
- Ucsd, Avrc Crs - San Diego
- San Mateo County AIDS Program - San Mateo
- Harbor-UCLA Med. Ctr. CRS - Torrance
Illinois
- Northwestern University CRS - Chicago
- Weiss Memorial Hosp. - Chicago
Indiana
- Indiana Univ. School of Medicine, Wishard Memorial - Indianapolis
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
Massachusetts
- Massachusetts General Hospital ACTG CRS - Boston
- Beth Israel Deaconess Med. Ctr., ACTG CRS - Boston
Missouri
- St. Louis ConnectCare, Infectious Diseases Clinic - St Louis
- Washington U CRS - St Louis
Alabama
- Alabama Therapeutics CRS - Birmingham
Colorado
- University of Colorado Hospital CRS - Aurora
Florida
- Univ. of Miami AIDS CRS - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Est. Completion | 2004-08 |
| Phase | Phase 2 |
What the finished NCT00000916 record still lists
NCT00000916 is an interventional study that assigns participants to a tested intervention. The registered 399 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (10% lower).
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 5 interventions - of which Hydroxyurea is the first listed.
NCT00000916 names 20 study sites across 13 states, led by California, Illinois, Indiana.
Frequently Asked Questions
What is clinical trial NCT00000916 about?
NCT00000916 is a clinical study titled "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". 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 ...
What is the current status of trial NCT00000916?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 399 participants. Estimated completion is 2004-08.
What conditions does trial NCT00000916 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000916?
The interventions under investigation include: Hydroxyurea (DRUG), Lamivudine (DRUG), Indinavir sulfate (DRUG), Stavudine (DRUG), Lamivudine/Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00000916?
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 NCT00000916 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Hawaii. 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 NCT00000916's enrollment target sits among peer trials
399 84th of 542 higher than 458 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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