Immune Responses in HIV-Positive Patients Receiving an Anti-HIV Drug Combination When Given the HIV Vaccines Remune and vCP1452

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to see how the vaccines Remune (HIV-1 immunogen) and vCP1452 affect immune responses in patients who also are taking anti-HIV medications. This study also will see if these vaccines are safe to use either alone or in combination. Treatment with anti-HIV drugs does not always keep HIV viral load low and under control. This study will look at the effect of the HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about immune responses and the safety of these vaccines in HIV-positive patients will be gathered.

Key facts

Study ID

NCT00006495

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

80

Expected to finish

2004-09-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for Step I of this study if they:
• Are at least 18 years old.
• Are HIV-infected.
• Have been on stable anti-HIV combination drug therapy for at least 12 weeks prior to screening for viral load and are willing to continue the same treatment during the study unless they experience side effects from the drugs and have a viral load increase.
• Have a viral load lower than 50 copies/ml at screening. Patients must have had a viral load below 500 copies/ml for at least 12 weeks prior to screening.
• Have a CD4 T cell count of at least 300 cells/mm3 within 30 days prior to study entry.
• Agree to practice acceptable methods of birth control, including male and female condoms, a diaphragm, or an intra-uterine device (IUD), while on study treatment and for 12 weeks after study treatment is discontinued.
• Patients may be eligible for Step II of this study if they:
• Are enrolled in A5058s under A5057/A5058s, Versions 1.0 and 2.0.

You may not qualify if…

• Patients will not be eligible for Step I of this study if they:
• Are pregnant or breast-feeding.
• Have an acute infection requiring antibiotics, an outbreak of a herpes virus, or other illness or surgery within 30 days prior to entry.
• Have a long-term infection other than HIV.
• Have cancer that may require systemic treatment.
• Have had lymph node irradiation.
• Have received any HIV vaccine.
• Have used GM-CSF, G-CSF, M-CSF, IFN, IL-2, or similar medication within 30 days prior to entry.
• Have used drugs affecting the immune system within 30 days prior to entry, or have an illness that may require use of these drugs.
• Have had immunizations within 30 days prior to study entry.
• Have received hydroxyurea within 30 days prior to study entry.
• Are allergic to egg proteins or neomycin or have had other serious allergic reactions.
• Work in close contact with canaries, or react to canarypox. Persons with a pet canary are not excluded.
• Have had 2 viral load measurements in a row taken at least 14 days apart that were 500 copies/ml or higher in the 12 weeks prior to screening.

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Univ. of Miami AIDS CRS — Miami, Florida, 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
• Univ. of Rochester ACTG CRS — Rochester, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States
• Univ. of Texas Medical Branch, ACTU — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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