- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005779
Safety of the Candidate Vaccine C4-V3 Alone or With Interleukin-12 (IL-12) in HIV-Infected Patients Receiving Effective Anti-HIV Drug Therapy
A Phase I, Limited-Center, Sequential Cohort Trial of HIV Vaccine (Polyvalent Peptide Vaccine C4-V3) in Conjunction With Interleukin-12 in Subjects With Maximal Suppression of HIV Replication and CD4 Count > 400 Cells/mm3
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cytotoxic T lymphocyte (CTL) responses are important to the initial decrease in HIV viral load seen in the first several months after acute infection. These beneficial CTL responses diminish with disease progression and cannot be recovered with antiretroviral therapy alone. Recent studies suggest a vaccine may help restore CTL responses. This study tests the effectiveness of the C4-V3 vaccine, a synthetic peptide vaccine representing 4 epitopes from HIV gp120, including an HLA B7-restricted CTL epitope. Administering IL-12, an immunostimulatory cytokine, in conjunction with C4-V3 may enhance HIV-1 specific immune responses and global immune function.
All patients continue their antiretroviral regimen during the study. Twelve patients are assigned equally to 1 of 3 cohorts; all patients receive 4 doses of C4-V3. Cohort 1 receives C4-V3 alone; once all 4 patients have received 2 doses and completed 8 weeks of treatment, toxicity data are reviewed. Barring serious adverse events, 4 patients are enrolled in Cohort 2 to receive C4-V3 plus a low dose of IL-12 near the vaccine injection sites. Once all 4 patients have received 2 doses of C4-V3/IL-12 and completed 8 weeks of treatment, toxicity data are reviewed. Barring serious adverse events, 4 patients are enrolled in Cohort 3 to receive C4-V3 plus a higher dose of IL-12 administered as above. [AS PER AMENDMENT 8/1/00: Twenty patients are assigned equally to 1 of 5 cohorts; all patients receive 4 doses of C4-V3. Cohort 1 receives C4-V3 alone; once all 4 patients have received 2 doses and completed 6 weeks of treatment, toxicity data are reviewed. Barring serious adverse events, 4 additional patients are enrolled in Cohort 2 to receive C4-V3 plus a low dose (dose level 1) of IL-12. Barring serious adverse events, 4 additional patients are enrolled in Cohort 3 to receive C4-V3 plus a higher dose (dose level 2) of IL-12. Barring serious adverse events, 4 additional patients are enrolled in Cohort 4 to receive C4-V3 plus a higher dose (dose level 3) of IL-12. Barring serious adverse events, 4 patients are enrolled in Cohort 5 to receive C4-V3 plus a higher dose (dose level 4) of IL-12.] Patients are followed for safety evaluations and changes in viral load through Week 48. If toxicity related to C4-V3 or IL-12 persists through Week 48, the affected patients are followed until resolution of the toxicity.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush Presbyterian - Saint Luke's Med Ctr
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke Univ Med Ctr
-
-
Texas
-
Galveston, Texas, United States, 775550435
- Univ of Texas Galveston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Michelle Onorato
- Study Chair: Beverly Sha
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Adjuvants, Immunologic
- Interleukin-12
Other Study ID Numbers
- A5049
- 10893 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
- AACTG A5049
- ACTG A5049
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Interleukin-12
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedGastric Cancer | Colorectal Cancer | Pancreatic Cancer | Anal Cancer | Gallbladder CancerUnited States
-
National Cancer Institute (NCI)CompletedPrimary Peritoneal Cavity Cancer | Recurrent Ovarian Epithelial CancerUnited States
-
OncoSec Medical IncorporatedTerminatedMycosis Fungoides (MF) | Cutaneous T Cell Lymphomas (CTCL)United States
-
OncoSec Medical IncorporatedNational Cancer Institute (NCI)CompletedMerkel Cell CarcinomaUnited States
-
OncoSec Medical IncorporatedTerminatedHead and Neck Squamous Cell CarcinomaUnited States
-
OncoSec Medical IncorporatedCompleted
-
National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma | Recurrent Adult Immunoblastic... and other conditionsUnited States
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)CompletedHead and Neck CancerUnited States
-
University of ChicagoNational Cancer Institute (NCI)Completed
-
Indiana University School of MedicineNational Cancer Institute (NCI)CompletedLymphoma | Kidney Cancer | Myelodysplastic Syndromes | Leukemia | Testicular Germ Cell Tumor | Breast Cancer | Chronic Myeloproliferative Disorders | Ovarian Cancer | Gestational Trophoblastic Tumor | Neuroblastoma | Multiple Myeloma and Plasma Cell NeoplasmUnited States