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

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interleukin-12; Vaccines

Criteria

Inclusion Criteria

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.)

Exclusion Criteria

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.