Completed
A Randomized, Open Label Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Plus Antiretroviral Therapy vs. Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
72
Participants Needed
2
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 IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use.
CONDITIONS
Official Title
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
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 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 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.
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: 2 locations
1
Chulalongkorn Univ. Hosp. C603-010 CRS
Bangkok, Ratchathewi, Thailand
Status Unknown
2
Siriraj Hospital C603-020 CRS
Bangkok, Ratchathewi, Thailand
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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