Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients With HIV

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00011011

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

94

Starts

2001-02-01

Expected to finish

2006-10-01

Last updated by the study team

2021-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• Washington U CRS — St Louis, Missouri, United States
• Beth Israel Med. Ctr., ACTU — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• AIDS Care CRS — Rochester, New York, United States
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Case CRS — Cleveland, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• Univ. of Pennsylvania Health System, Presbyterian Med. Ctr. — Philadelphia, Pennsylvania, United States
• The Miriam Hosp. ACTG CRS — Providence, Rhode Island, United States
• University of Washington AIDS CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.