Safety and Effectiveness of Adding Either an HIV Vaccine, Interleukin-2, or Both to a Patient's Anti-HIV Drug Combination

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if adding an HIV vaccine (ALVAC-HIV vCP1452), IL-2 (interleukin-2, a protein found in the blood that helps boost the immune system), or both to anti-HIV-drug therapy is safe, tolerable, and effective in controlling viral load (level of HIV in the body). (This study has been changed to clarify drug name.) Anti-HIV drugs can help reduce a patient's viral load. However, HIV can still remain in CD4 cells (cells of the immune system that help fight infection). Combining an HIV vaccine, IL-2, or both with anti-HIV drugs may help reduce the number of HIV-infected cells.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aldesleukin; Interleukin-2; Vaccines

Criteria

Inclusion Criteria

Patients may be eligible to enter this study if they:

• Are HIV-positive.

• Have taken the same anti-HIV drugs for at least 6 months prior to study entry. A change of 1 drug to another similar drug is allowed in certain cases.

• Have a viral load of less than 50 copies/ml at screening and pre-entry. The measurements must be within 45 days of study entry.

• Have a CD4 cell count of at least 350 cells/mm3 within 45 days prior to study entry.

• Agree to use effective methods of birth control during the study and for 12 weeks after.

Exclusion Criteria

Patients may not be eligible for this study if they:

• Have or have had an AIDS-related illness (except Kaposi's sarcoma or Pneumocystis carinii pneumonia).

• Have had more than one potent antiretroviral regimen change due to virologic failure.

• Have a history of autoimmune disease with the exception of stable autoimmune thyroid disease.

• Have a history of allergy to eggs or other serious allergies.

• Have serious heart problems. Patients with high blood pressure controlled by blood pressure medication but no heart disease may be eligible for this study.

• Have cancer requiring chemotherapy.

• Have untreated thyroid disease. Patients who are on treatment and stable for at least 4 weeks before study entry are eligible.

• Have a serious central nervous system (CNS) disease or seizures, if these have been active within 1 year before study entry.

• Require certain heart medications for angina or arrhythmia.

• Are taking certain experimental anti-HIV drugs.

• Are taking certain drugs that may interfere with their anti-HIV-drug combination.

• Have taken drugs that might affect the immune system, within 4 weeks prior to study entry.

• Have taken IL-2 before.

• Have taken rifampin or rifabutin within 7 days before study entry if receiving indinavir.

• Have received therapy for an infection or any serious medical illness within 30 days before study entry.

• Have received immunizations within 30 days before study entry.

• Have received any HIV vaccine during the past year or at any time while on their present anti-HIV therapy.

• Work in close contact with canaries and are likely to have antibodies to the study vaccine prior to enrollment. (Patients with a pet canary may participate.)

• Abuse alcohol or drugs or have mental or learning problems.

• Are pregnant or breast-feeding.

• Have received abacavir or hydroxyurea within 8 weeks prior to study entry.

• Have a history of transplantation.

• (This study has been changed to reflect added criteria.)