Overview

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

Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Aldesleukin
Interleukin-2
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.