Status:
COMPLETED
The Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients With CD4 Cell Counts of at Least 350 Cells/mm3
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 IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system tha...
Detailed Description
IL-2, administered subcutaneously in combination with antiretrovirals, has resulted in increased CD4+ cell counts which may retard HIV disease progression. Using a smaller patient sampling, this Phase...
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a CD4 cell count greater than or equal to 300 cells/mm3.
- Have no AIDS-defining illnesses.
- Are at least 18 years old.
- Have been on antiretroviral therapy for at least 7 days prior to study entry.
Exclusion Criteria
Patients will not be eligible for this study if they:
- 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 the following: cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system abnormality, or an autoimmune/inflammatory disease.
- Are pregnant or breast-feeding.
- Have ever received IL-2.
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00000825
Start Date
May 1 1998
Last Update
October 29 2021
Active Locations (1)
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1
Thomas Street Clinic C605-020 CRS
Houston, Texas, United States, 77030