Safety of the Candidate Vaccine C4-V3 Alone or With Interleukin-12 (IL-12) in HIV-Infected Patients Receiving Effective Anti-HIV Drug Therapy

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if it is safe to give C4-V3, a possible HIV vaccine, alone or in conjunction with 4 different doses of interleukin-12 (IL-12), to HIV-infected patients who are taking anti-HIV drugs that have lowered the amount of HIV in patients' blood. (This study has been changed so that vaccine is administered alone or with 4 different doses of IL-12.) Immune cells known as cytotoxic T lymphocytes (CTLs) help destroy HIV-infected cells. However, in most patients, CTLs decrease over time. This allows HIV levels to rise and AIDS symptoms to develop. The C4-V3 vaccine contains small pieces of HIV protein that can boost CTL levels, allowing the body's immune system to fight HIV. Giving IL-12, a normal part of the immune system, with C4-V3 may make the vaccine more effective.

Key facts

Study ID

NCT00005779

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

12

Expected to finish

2004-05-01

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 this study if they:
• Are at least 18 years old.
• Are HIV-positive.
• Have 2 HIV measurements below 50 copies/ml taken at least 24 hours apart within 90 days prior to study entry.
• Have a CD4 count above 400 cells/mm3 within 30 days prior to study entry.
• Have been taking any combination of FDA-approved anti-HIV drugs for at least 3 months prior to study entry. (This study has been changed so that patients taking any combination of FDA-approved drugs for at least 3 months prior to study entry are included.)
• Test positive for HLA-B7.
• Agree to practice sexual abstinence or use 2 effective methods of birth control during the study and for 3 months after the study. (This study has been changed so that patients are required to use 2 effective methods of birth control.)

You may not qualify if…

• Patients will not be eligible for this study if they:
• Have ever received IL-12.
• Have received any vaccine within 30 days prior to study entry.
• Have chronic lung disease.
• Have participated in any other HIV vaccine trial.
• Have a history of autoimmune disease.
• Have gastrointestinal bleeding or peptic ulcer disease.
• Have received allergy skin testing or other allergy treatments within 30 days prior to study entry.
• Have received immunomodulatory or cytotoxic treatments within 30 days prior to study entry or will need to receive these treatments during the study.
• Have certain serious medical conditions or have received certain medications.
• Are pregnant or breast-feeding.

Where it is running

• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Univ of Texas Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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