Safety and Effectiveness of Adding Either an HIV Vaccine, Interleukin-2, or Both to a Patient's Anti-HIV Drug Combination
A Phase II, Randomized, Partially Blinded Trial of Combinations of Potent Antiretroviral Therapy, HIV-Specific Immunizations, and Cycles of Interleukin-2 to Promote Efficient Control of Viral Replication
4 other identifiers
interventional
100
2 countries
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedNovember 1, 2021
October 1, 2021
September 22, 2000
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, United States
USC CRS
Los Angeles, California, 900331079, United States
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
Stanford CRS
Palo Alto, California, 943055107, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
Santa Clara Valley Med. Ctr.
San Jose, California, 951282699, United States
San Mateo County AIDS Program
San Mateo, California, 943055107, 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, 90502, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Univ. of Miami AIDS CRS
Miami, Florida, 331361013, United States
The Ponce de Leon Ctr. CRS
Atlanta, Georgia, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 462025250, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
Beth Israel Med. Ctr., ACTU
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Unc Aids Crs
Chapel Hill, North Carolina, 275997215, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, 37203, United States
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 775550435, United States
Puerto Rico-AIDS CRS
San Juan, 009365067, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Kilby
- STUDY CHAIR
Ronald Mitsuyasu
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2000
First Posted
August 31, 2001
Study Completion
October 1, 2005
Last Updated
November 1, 2021
Record last verified: 2021-10