Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People
Public ClinicalTrials.gov record NCT00110812. 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
STALWART: A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 With and Without Concomitant Antiretroviral Therapy in Patients With HIV-1 Infection and CD4+ Cell Counts of 300 Cells/mm3 or More
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine the effect of short cycles of recombinant interleukin-2 (also known as rIL-2 or aldesleukin) given with or without anti-HIV drugs in HIV infected patients. The effects will be compared with a study group that receives no IL-2 or antiretroviral therapy. Study hypothesis: Intermittent aldesleukin, when given without antiretroviral therapy to patients with early HIV infection, will produce no change in HIV viral load and increases in CD4+ T lymphocyte counts comparable to aldesleukin administered with antiretrovirals.
Study identification
- NCT ID
- NCT00110812
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 267 participants
Conditions and interventions
Conditions
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
- Aug 31, 2005
- Primary completion
- Jan 31, 2011
- Completion
- Jan 31, 2011
- Last update posted
- Nov 3, 2021
2005 – 2011
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS | Los Angeles | California | 90073 | — |
| Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS | Washington D.C. | District of Columbia | 20422 | — |
| NIH Clinical Ctr., NIAID HIV Clinic CRS | Bethesda | Maryland | 20814-9692 | — |
| Henry Ford Hosp. CRS | Detroit | Michigan | 48202 | — |
| Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) | New York | New York | 10037 | — |
| Lincoln Hosp. & Med. Ctr. CRS | The Bronx | New York | 10451 | — |
| Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS | Portland | Oregon | 97213 | — |
| Michael E. DeBakey VAMC CRS | Houston | Texas | 77030 | — |
| Thomas Street Clinic CRS | Houston | Texas | 77030 | — |
| South Texas Veterans Health Care System, Immunosuppression Clinic CRS | San Antonio | Texas | 78229 | — |
| Virginia Commonwealth Univ. Medical Ctr. CRS | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00110812, 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 Nov 3, 2021 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00110812 live on ClinicalTrials.gov.