Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00000870 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone
A Phase 2 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT00000870 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 200 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT00000870, 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
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
To compare two different routes of intermittently administered rhIL-2 with a highly active antiretroviral regimen (HAART) to HAART alone. The comparison is based on the following: proportion of patients achieving at least 50-percent increase in CD4 counts above prerandomization baseline values after 1 year of rhIL-2 and the rate of change in CD4 counts. To compare the safety and tolerance of these regimens and their effect on quality of life. To assess the effects of rhIL-2 when combined with HAART on changes in immune cell phenotypes and function and on HIV viral load and the rate of antiviral drug resistance development. The poor responsiveness of late stage HIV-infected patients to rhIL-2 is thought to occur because of low T cell regenerative capacity and high viral burden. If means were available to effectively suppress virus replication, the indigenous immune restorative responses of the host may be further stimulated and enhanced by rhIL-2. The use of protease inhibitors with nucleoside-analogue combination regimens appears to be most effective in controlling virus replication. High-dose intermittent rhIL-2 administered either intravenously or subcutaneously has been shown to be effective in inducing CD4 responses in a number of studies.
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Indinavir sulfate
- DRUG Stavudine
- DRUG Didanosine
Study Locations (20)
New York
- Beth Israel Med. Ctr. (Mt. Sinai) - New York
- NY Univ. HIV/AIDS CRS - New York
- Weill Med. College of Cornell Univ., The Cornell CTU - New York
- Mt. Sinai Med. Ctr. (N.Y.) A1801 CRS - New York
California
- USC CRS - Los Angeles
- Stanford CRS - Palo Alto
- Harbor-UCLA Med. Ctr. CRS - Torrance
North Carolina
- Unc Aids Crs - Chapel Hill
- Duke Univ. Med. Ctr. Adult CRS - Durham
Ohio
- Case CRS - Cleveland
- The Ohio State Univ. AIDS CRS - Columbus
Alabama
- Alabama Therapeutics CRS - Birmingham
Colorado
- University of Colorado Hospital CRS - Aurora
Hawaii
- Univ. of Hawaii at Manoa, Leahi Hosp. - Honolulu
Iowa
- Univ. of Iowa Healthcare, Div. of Infectious Diseases - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Est. Completion | 2007-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000870
The ClinicalTrials.gov registry entry for NCT00000870 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 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 (55% 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 Zidovudine is the first listed.
NCT00000870 reports 20 study locations spanning 13 distinct geographic areas - top geographies include New York, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00000870 about?
NCT00000870 is a clinical study titled "A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone". To compare two different routes of intermittently administered rhIL-2 with a highly active antiretroviral regimen (HAART) to HAART alone. The comparison is based on the following: proportion of patients achieving at least 50-percent increase in CD4 counts above prerandomization baseline values after...
What is the current status of trial NCT00000870?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. Estimated completion is 2007-03.
What conditions does trial NCT00000870 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00000870?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Indinavir sulfate (DRUG), Stavudine (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00000870?
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 NCT00000870 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Hawaii, Iowa. 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.