A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons

Tracking Information
First Submitted Date ICMJE	November 2, 1999
First Posted Date ICMJE	August 31, 2001
Last Update Posted Date	May 6, 2013
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00001060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
Official Title ICMJE	A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
Brief Summary	To determine the safety of immunization with HIV-1 C4-V3 polyvalent peptide vaccine in HIV-infected persons. To determine the proportion of study participants immunized who develop new specificities or increased levels of neutralizing and other antibody responses, T-cell proliferative responses, and Class I restricted cytotoxic T-lymphocyte ( CTL ) responses. HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes from four of the most common HIV isolates in the United States and Europe, predicted to represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes that generate potentially salutary immune responses and deletes epitopes that generate immune responses which might contribute to further immunopathogenesis.
Detailed Description	HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes from four of the most common HIV isolates in the United States and Europe, predicted to represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes that generate potentially salutary immune responses and deletes epitopes that generate immune responses which might contribute to further immunopathogenesis. Patients are randomized to receive low-dose or high-dose HIV-1 C4-V3 polyvalent peptide vaccine in incomplete Freund's adjuvant (IFA), or IFA alone as control. Injections are administered on day 0 and at weeks 4, 8, 12, and 24. When patients entered at the lower vaccine dose (Cohort A) reach week 6, the data is reviewed and the higher dose cohort (Cohort B) will begin. When both cohorts reach week 14, data is evaluated and Cohort C begins vaccine administrations at a chosen vaccine dose. Within each cohort, eight patients receive vaccine plus IFA and two patients receive IFA alone. Patients are followed to week 52; 18 clinic visits and four telephone calls are required.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Masking: Double; Primary Purpose: Prevention
Condition ICMJE	HIV Infections
Intervention ICMJE	Biological: HIV-1 C4-V3 Polyvalent Peptide Vaccine
Study Arms	Not Provided
Publications *	Bartlett JA, Wasserman SS, Hicks CB, Dodge RT, Weinhold KJ, Tacket CO, Ketter N, Wittek AE, Palker TJ, Haynes BF. Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative. AIDS. 1998 Jul 30;12(11):1291-300.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	30
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2002
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria Concurrent Medication: Allowed: Other medically indicated vaccinations, provided they are administered at least 2 weeks before or after any study injection.; Alcohol use limited to 1 oz per day of 100 proof. Patients must have: HIV infection without evidence of AIDS.; CD4 count > 500 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Current evidence of underlying lung or liver disease.; Suspected or diagnosed allergy to any vaccine component.; Medical contraindication to protocol participation.; Undergoing allergy skin testing or desensitization. Concurrent Medication: Excluded: Antiretroviral therapy (unless clinically indicated and with approval of investigator).; Immunosuppressive or immunomodulatory therapy.; Nonsteroidal anti-inflammatory agents (except short-term therapy for acute conditions).; Drugs with known hepatotoxicity.; Alcohol intake > 1 oz per day of 100 proof. Patients with the following prior conditions are excluded: History of underlying lung disease.; Abnormal chest radiograph within 2 weeks prior to first vaccine injection.; History of underlying liver disease.; Abnormal hepatitis B surface antigen or hepatitis C antibody test within 2 weeks prior to first vaccine injection.; Abnormal liver function tests within 30 days prior to study entry.; Evidence of uveitis by slit lamp exam within 2 weeks prior to study entry.; Anergic as evidenced by negative skin test responses to all three antigens in a panel consisting of tetanus toxoid, mumps, and Candida albicans, within 6 weeks prior to first vaccine injection.; Prior participation on an HIV vaccine trial. Prior Medication: Excluded within the past 3 months: Antiretroviral therapy.; Immunosuppressive drugs.; Alpha interferon or any immunomodulatory drugs.; Any investigational HIV drugs or therapies. Current alcohol abuse.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00001060
Other Study ID Numbers ICMJE	DATRI 101; 11741 ( Registry Identifier: DAIDS ES Registry Number ); DATRI 0101
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ICMJE	Lederle-Praxis Biologicals
Investigators ICMJE	Study Chair: Bartlett JA Study Chair: Tacket CO Study Chair: Virani-Ketter N
PRS Account	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	May 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP