Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients With HIV
A Randomized Phase I/II Pilot Study of Intermittent Withdrawal of Antiretroviral Therapy as an Immunization Strategy and Double-Blinded Immunization With ALVAC-HIV vCP1452 in Subjects With Persistent CD4+ Cell Counts Greater Than 400 Cells/mm3 and Plasma HIV-1 RNA Levels Less Than 50 Copies/ml
7 other identifiers
interventional
94
1 country
16
Brief Summary
Long-term control of HIV depends on improvement in an individual's immune system. The purpose of this study is to see if either stopping anti-HIV drugs for short periods of time and/or adding a vaccine to the anti-HIV drugs being taken will help to better control HIV infection. The study will test whether these treatment approaches are safe. The HIV vaccine in this study has been tested in people who did not have HIV infection and improved the way their immune system worked. This study will evaluate whether these same immune system changes happen in people with HIV, and, if such changes do occur, assess whether these changes help to improve control of HIV in these patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Feb 2001
Longer than P75 for phase_1 hiv-infections
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
February 8, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedNovember 1, 2021
October 1, 2021
February 8, 2001
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- HIV infection
- CD4 count greater than 400 cells/mm3 within 6 months before study entry
- Current, persistent viral load below 400 copies/ml for 6 months before study entry and under 50 copies/ml at study screening
- Currently receiving their first combination ART regimen (3 or more antiretrovirals) for at least 4 weeks before screening, or if the current potent ART regimen is not their first potent ART regimen, must have been receiving the current regimen for at least 4 weeks prior to screening
- Negative pregnancy test within 45 days before study entry
- Acceptable methods of contraception
- Provide informed consent
You may not qualify if:
- Immunomodulators within 45 days of study entry such as systemic corticosteroids, interferons, interleukins, thalidomide, sargramostim (granulocyte-macrophage colony-stimulating factor \[GM-CSF\]), dinitrochlorobenzene (DNCB), thymosin alpha, thymopentin, inosiplex, polyribonucleoside, and ditiocarb sodium
- Abacavir within 8 weeks of study entry
- Infection or medical illness within 14 days of study entry
- Cancer that may require systemic therapy
- History of lymph node radiation therapy
- Prior HIV vaccine
- Received hydroxyurea within 45 days of study entry
- Close contact with canaries through work (e.g., breeding farms, bird shops); patients with a pet canary are not excluded
- Abuse or dependence on drugs or alcohol
- Allergic to albumin
- Pregnant or breastfeeding
- Infected with HIV within 1 year of study entry
- Interruption of potent ART for more than 7 consecutive days within 1 year of study entry
- History of allergy to egg proteins or neomycin
- History of other serious acute allergic reactions (e.g., anaphylaxis, allergy-induced asthma, Stevens-Johnson syndrome, toxic epidermal necrolysis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Alabama Therapeutics CRS
Birmingham, Alabama, 35294, United States
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Washington U CRS
St Louis, Missouri, 63110, 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
AIDS Care CRS
Rochester, New York, 14607, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27599, United States
Case CRS
Cleveland, Ohio, 44106, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Univ. of Pennsylvania Health System, Presbyterian Med. Ctr.
Philadelphia, Pennsylvania, 19104, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, 02906, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Related Publications (4)
Ferrari G, Berend C, Ottinger J, Dodge R, Bartlett J, Toso J, Moody D, Tartaglia J, Cox WI, Paoletti E, Weinhold KJ. Replication-defective canarypox (ALVAC) vectors effectively activate anti-human immunodeficiency virus-1 cytotoxic T lymphocytes present in infected patients: implications for antigen-specific immunotherapy. Blood. 1997 Sep 15;90(6):2406-16.
PMID: 9310492BACKGROUNDRosenberg ES, Billingsley JM, Caliendo AM, Boswell SL, Sax PE, Kalams SA, Walker BD. Vigorous HIV-1-specific CD4+ T cell responses associated with control of viremia. Science. 1997 Nov 21;278(5342):1447-50. doi: 10.1126/science.278.5342.1447.
PMID: 9367954BACKGROUNDBelshe RB, Gorse GJ, Mulligan MJ, Evans TG, Keefer MC, Excler JL, Duliege AM, Tartaglia J, Cox WI, McNamara J, Hwang KL, Bradney A, Montefiori D, Weinhold KJ. Induction of immune responses to HIV-1 by canarypox virus (ALVAC) HIV-1 and gp120 SF-2 recombinant vaccines in uninfected volunteers. NIAID AIDS Vaccine Evaluation Group. AIDS. 1998 Dec 24;12(18):2407-15. doi: 10.1097/00002030-199818000-00009.
PMID: 9875578BACKGROUNDJacobson JM, Pat Bucy R, Spritzler J, Saag MS, Eron JJ Jr, Coombs RW, Wang R, Fox L, Johnson VA, Cu-Uvin S, Cohn SE, Mildvan D, O'Neill D, Janik J, Purdue L, O'Connor DK, Vita CD, Frank I; National Institute of Allergy and Infectious Diseases-AIDS Clinical Trials Group 5068 Protocol Team. Evidence that intermittent structured treatment interruption, but not immunization with ALVAC-HIV vCP1452, promotes host control of HIV replication: the results of AIDS Clinical Trials Group 5068. J Infect Dis. 2006 Sep 1;194(5):623-32. doi: 10.1086/506364. Epub 2006 Aug 1.
PMID: 16897661RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jeffrey M. Jacobson, MD
Beth Israel Medical Center
- STUDY CHAIR
Ian Frank, MD
Division of Infectious Diseases, University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2001
First Posted
August 31, 2001
Study Start
February 1, 2001
Study Completion
October 1, 2006
Last Updated
November 1, 2021
Record last verified: 2021-10