Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination
A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Effect of Immunization With an HIV Immunogen on the Time to Virologic Relapse in Individuals Receiving Potent, Suppressive Antiretroviral Therapies
5 other identifiers
interventional
472
1 country
17
Brief Summary
The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load (level of HIV in the blood) and on the way the immune system responds to HIV. This study will also try to see if the effects of the vaccine are different in patients entering the study with a viral load below 50 copies/ml compared to those who have a viral load from 50 to 500 copies/ml. (This study is currently being redesigned and the purpose may be revised.) Treatment with anti-HIV drugs does not always keep HIV viral load undetectable (so low that it cannot be measured). This study originally added an HIV vaccine called Remune to treat patients. Remune was thought to reduce viral load and improve immune responses. However, new information suggests that Remune may not be as effective as was first believed. The study has been changed to follow people already in the study and to let people enroll only if they participate in the substudy. The substudy will look at the effect of another HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about the safety of these vaccines in HIV-positive patients will be gathered.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
17 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
May 23, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedNovember 1, 2021
October 1, 2021
May 23, 2000
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have been on certain anti-HIV drugs for at least 3 months and intend to continue the same anti-HIV drugs unless they develop side effects to the drugs or their viral load rises above a certain level.
- Have a viral load of less than 500 copies/ml for at least 3 months before entering the study.
- Have a CD4 count of at least 300 cells/mm3.
- Are at least 14 years old (consent of parent or guardian required if under 18).
- Agree to practice barrier methods of birth control (such as condoms) while on the study and for 3 months after the study ends.
- Patients may be eligible for the substudy if they:
- Are at least 18 years old.
- Have a plasma HIV viral load below 50 copies/ml.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have had an infection requiring antibiotics, an outbreak of herpes simplex virus (HSV) or herpes zoster, or other illness or surgery within 30 days of study entry. (This study has been changed to exclude patients who have had an outbreak of HSV or herpes zoster or have had surgery within 30 days of study entry.)
- Currently have any long-term infection other than HIV.
- Have cancer that requires chemotherapy.
- Have had lymph node irradiation.
- Have ever received an HIV vaccine.
- Have taken certain drugs affecting the immune system within 30 days of study entry.
- Have taken hydroxyurea within 30 days of study entry.
- Have received any vaccine within 30 days of study entry.
- Patients will not be eligible for the substudy if they:
- Have a history of allergies to egg proteins or neomycin, or a history of other serious allergic reactions.
- Ever worked closely with canaries in a bird shop or breeding farm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
USC CRS
Los Angeles, California, 900331079, United States
Stanford CRS
Palo Alto, California, 943055107, United States
Ucsf Aids Crs
San Francisco, California, 941102859, United States
Univ. of Miami AIDS CRS
Miami, Florida, 331361013, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, 02215, United States
Bmc Actg Crs
Boston, Massachusetts, 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
Case CRS
Cleveland, Ohio, 44106, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, 19104, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fred Valentine
- STUDY CHAIR
Laurence Peiperl
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2000
First Posted
August 31, 2001
Study Completion
September 1, 2005
Last Updated
November 1, 2021
Record last verified: 2021-10