Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00006509
NCT00006509
Completed
Phase 1

A Phase I/II Safety and Immunogenicity Evaluation of a Prime/Boost Vaccine Using ALVAC-HIV (vCP 1452) With Recombinant gp160 LAI/MN-2 in HIV-Infected Subjects Treated With Antiretroviral Therapy for a Minimum of 2 Years

National Institute of Allergy and Infectious Diseases (NIAID)1 site in 1 country12 target enrollmentAugust 31, 2001
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHIV Infections

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
HIV Infections
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment
12
Locations
1
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to see if 2 study vaccines, ALVAC-HIV (vCP1452) and gp160 MN/LAI-2, are safe and effective in boosting the body's attacks on HIV in HIV-positive patients.

HIV-infected patients who have been treated with anti-HIV drugs for a long time may have weakened immune responses. One way to strengthen these responses may be to have a safe and effective vaccine, which will boost immune responses that are specific to HIV.

Detailed Description

HIV-infected patients treated with antiretroviral therapy for prolonged periods of time may show decreased levels of HIV-specific immune responses. In these patients, a prime-boost vaccine strategy may induce both humoral and cell-mediated immunity. The hypothesis of this study is that the vaccine strategy selected will be both safe and immunogenic in the patient population being tested. Patients continue antiretroviral medications throughout the course of this study. All patients receive intramuscular injections of ALVAC-HIV (vCP 1452) and recombinant soluble gp160 MN/LAI-2 on Days 0, 30, 90, and 180. Patients are monitored for safety 30 minutes after each immunization and by telephone contact within 72 hours of each vaccination. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.

Registry
clinicaltrials.gov
Start Date
August 31, 2001
End Date
June 2007
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 1
A Study of the Effects of Giving Two Anti-HIV Vaccines to Babies of HIV-Positive MothersHIV InfectionsHIV Seronegativity
NCT00000879National Institute of Allergy and Infectious Diseases (NIAID)48
Completed
Phase 1
A Study of LIPO-5 and ALVAC-HIV (vCP1452) as Possible HIV VaccinesHIV Infections
NCT00076063National Institute of Allergy and Infectious Diseases (NIAID)174
Completed
Phase 1
Safety of and Immune Response to Two HIV Vaccine Formulations (rMVA-HIV and rFPV-HIV) Alone or in Combination in HIV Uninfected AdultsHIV Infections
NCT00083603National Institute of Allergy and Infectious Diseases (NIAID)150
Withdrawn
Phase 1
Evaluating the Safety and Immune Response to Two HIV Vaccine Regimens in Healthy, HIV-Uninfected Adults in the United States and South AfricaHIV Infections
NCT01927835National Institute of Allergy and Infectious Diseases (NIAID)
Completed
Phase 1
Phase 1 Safety Study of Two Experimental HIV VaccinesAIDS VaccinesHIV InfectionsHIV-1
NCT00479999National Institute of Allergy and Infectious Diseases (NIAID)35