Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if HIV-specific canarypox vaccine and/or interleukin-2 (IL-2) will control viral load (amount of HIV in the blood) after HIV treatment is withdrawn for a certain time period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: New York Presbyterian Hospital
• Treatments: Aldesleukin

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Are more than 18 years old.

• Have been receiving their current HAART (2 or more anti-HIV drugs in combination) for more than 6 consecutive months.

• Have a CD4 count of 200 cells/microL or more within the 12 months prior to entering the study and 400 cells/microL or more on 2 occasions at least 2 weeks apart within 30 days of entry.

• Have never had a viral load higher than 2 million molecules/ml and have had the viral load controlled with HAART to less than 50 molecules/ml on 2 occasions at least 2 weeks apart within 30 days of entry.

• Have not had virologic failure on the current HAART regimen.

• Have a negative urine pregnancy test within 14 days of entering the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have a current AIDS-defining illness.

• Have had failure of the current HAART regimen (viral load higher than 10,000 molecules/ml).

• Have a history of using agents affecting the immune system.

• Have active uncontrolled heart disease.

• Have had IL-2 therapy within 4 weeks of entering the study.

• Have received other treatment that affects the immune system within 4 weeks of entry.

• Have a history of a cancer requiring chemotherapy.

• Have untreated thyroid disease, within 4 weeks of entering the study.

• Have uncontrolled allergic disorders or autoimmune diseases, including asthma, inflammatory bowel disease, and psoriasis.

• Abuse substances that may interfere with the ability to follow study requirements.

• Are allergic to eggs.

• Have hepatitis B or hepatitis C.

• Are pregnant or breast-feeding.

• Work in close contact with canaries, such as a job at breeding farms or bird shops.