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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00006291

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

100

Expected to finish

2005-10-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Santa Clara Valley Med. Ctr. — San Jose, California, United States
• San Mateo County AIDS Program — San Mateo, California, United States
• Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic — San Rafael, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• The Ponce de Leon Ctr. CRS — Atlanta, Georgia, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Indiana Univ. School of Medicine, Wishard Memorial — Indianapolis, Indiana, United States
• Methodist Hosp. of Indiana — Indianapolis, Indiana, United States
• University of Minnesota, ACTU — Minneapolis, Minnesota, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• Vanderbilt Therapeutics CRS — Nashville, Tennessee, United States
• Univ. of Texas Medical Branch, ACTU — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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