Status:
COMPLETED
A Study to Evaluate the Effects of Giving IL-2 Alone to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3 Who Do Not Wish to Receive Anti-HIV Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of giving interleukin-2 (IL-2) alone to HIV-positive patients with CD4 cell counts greater than 350 cells/mm3 who do not wish to re...
Detailed Description
Previous studies have shown that interleukin-2, when given under the skin, results in CD4+ cell count increases, and may impact upon disease progression. A Phase III trial is the next step in the deve...
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have had at least one CD4 cell count greater than or equal to 350 cells/mm3 within 30 days of study entry.
- Are at least 18 years old.
- Agree to abstinence or use of effective methods of birth control 1 month before and during the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a history of a potentially life-threatening autoimmune or inflammatory disease.
- Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.
- Have a history of an AIDS-defining illness.
- Have a history of cancer, other than Kaposi's sarcoma.
- Have ever taken IL-2 or any antiretroviral medications.
- Are pregnant.
- Are taking certain medications, including anti-seizure medications.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00000909
End Date
June 1 2004
Last Update
October 29 2021
Active Locations (1)
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1
Kobler Ctr. of Chelsea Westminster Hosp. C604-030 CRS
London, United Kingdom