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
Public ClinicalTrials.gov record NCT00000870. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00000870
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Interventions
- Indinavir sulfate Drug
- Lamivudine Drug
- Stavudine Drug
- Zidovudine Drug
- Didanosine Drug
- Aldesleukin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 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
- Feb 28, 2007
- Last update posted
- May 20, 2012
Ends 2007
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Therapeutics CRS | Birmingham | Alabama | 35294 | — |
| USC CRS | Los Angeles | California | 900331079 | — |
| Stanford CRS | Palo Alto | California | 943055107 | — |
| Harbor-UCLA Med. Ctr. CRS | Torrance | California | 90502 | — |
| University of Colorado Hospital CRS | Aurora | Colorado | 80262 | — |
| Univ. of Hawaii at Manoa, Leahi Hosp. | Honolulu | Hawaii | 96816 | — |
| Univ. of Iowa Healthcare, Div. of Infectious Diseases | Iowa City | Iowa | 52242 | — |
| Tulane Univ. A1701 CRS | New Orleans | Louisiana | 70112 | — |
| Beth Israel Deaconess - East Campus A0102 CRS | Boston | Massachusetts | 02215 | — |
| St. Louis ConnectCare, Infectious Diseases Clinic | St Louis | Missouri | 63112 | — |
| Beth Israel Med. Ctr. (Mt. Sinai) | New York | New York | 10003 | — |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | — |
| Weill Med. College of Cornell Univ., The Cornell CTU | New York | New York | 10021 | — |
| Mt. Sinai Med. Ctr. (N.Y.) A1801 CRS | New York | New York | 10029 | — |
| Unc Aids Crs | Chapel Hill | North Carolina | 275997215 | — |
| Duke Univ. Med. Ctr. Adult CRS | Durham | North Carolina | 27710 | — |
| Case CRS | Cleveland | Ohio | 44106 | — |
| The Ohio State Univ. AIDS CRS | Columbus | Ohio | 432101228 | — |
| Univ. of Texas Medical Branch, ACTU | Galveston | Texas | 775550435 | — |
| University of Washington AIDS CRS | Seattle | Washington | 981224304 | — |
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 NCT00000870, 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 May 20, 2012 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00000870 live on ClinicalTrials.gov.