Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000916
The ClinicalTrials.gov registry entry for NCT00000916 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 399 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 (10% 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 5 interventions - of which Hydroxyurea is the first listed.
NCT00000916 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
-
A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study)
RECRUITING · Phase 2
-
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
RECRUITING · Phase 2
-
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
RECRUITING · Phase 2
-
Imaging Immune Activation in HIV by PET-MR
RECRUITING · Phase 2
-
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)
ACTIVE NOT RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.