Overview

A Study to Evaluate 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

Status:
Completed
Trial end date:
1999-12-01
Target enrollment:
0
Participant gender:
All
Summary
To demonstrate the safety and tolerability of subcutaneously administered interleukin-2 (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone. 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.
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

You may be eligible for this study if you:

- Are HIV-positive.

- Have a CD4 cell count greater than or equal to 300 cells/mm3.

- Are at least 18.

- Have been on antiretroviral therapy for at least 7 days prior to study entry.

Exclusion Criteria

You will not be eligible for this study if you:

- Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that
would affect your 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 (CNS) abnormality, or an autoimmune/inflammatory disease.

- Are pregnant or breast-feeding.

- Have ever received IL-2.