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

NCT00005779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-11-01

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Interleukin-12

BIOLOGICAL

HIV-1 C4-V3 Polyvalent Peptide Vaccine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Michelle Onorato

  • Beverly Sha

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2004-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005779 on ClinicalTrials.gov