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 | Completed Phase 1

• 4 other identifiers: A5049AACTG A504910893ACTG A5049
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Virus Replication; HIV-1; AIDS Vaccines; CD4 Lymphocyte Count; Cohort Studies; Interleukin-12; HIV Therapeutic Vaccine

Interventions

Interleukin-12 DRUG

HIV-1 C4-V3 Polyvalent Peptide Vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Univ of Texas Galveston

Galveston, Texas, 775550435, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Interleukin-12

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Michelle Onorato

  STUDY CHAIR

• Beverly Sha

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2000
• First Posted: August 31, 2001
• Study Completion: May 1, 2004
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (3)