Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00005758

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

472

Expected to finish

2005-09-01

Last updated by the study team

2021-11-01

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• USC CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, 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
• Case CRS — Cleveland, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• Vanderbilt Therapeutics CRS — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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