Completed
A Randomized, Open Label Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Alone vs No Therapy in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3 Who Do Not Wish to Receive Treatment With Antiretroviral Therapy
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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 receive anti-HIV (antiretroviral) therapy. This study will also determine if IL-2 given alone can increase CD4 cell counts or decrease the level of HIV in the blood. IL-2 (a protein found in the blood that helps boost the immune system) can result in increases in CD4 cell count (immune system cells that fight infection). IL-2 is normally given in combination with antiretroviral therapy to treat HIV infection; however, some HIV patients do not wish to take antiretrovirals. This study asks if it is safe and effective to take IL-2 alone to treat HIV infection.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
Kobler Ctr. of Chelsea Westminster Hosp. C604-030 CRS
London, United Kingdom
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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