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Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART

NCT00270205 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-11-04

Study results available
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Summary

LC002 is an experimental therapeutic vaccine designed to boost the immune response of people infected with HIV. The purpose of this study was to determine the safety and tolerability of and immune response to LC002 in HIV-1-infected adults who are currently receiving anti-HIV treatment.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

LC002 standard vaccination

0.1 mg DNA/participant, 0.8 ml total administered subcutaneously

BIOLOGICAL

LC002 high-dose vaccination

0.4 mg DNA/participant, 3.2 ml total administered subcutaneously

BIOLOGICAL

LC002 placebo vaccination

Placebo vaccination administered subcutaneously

Sponsors & Collaborators

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Benigno Rodriguez, MD · Division of Infectious Diseases ACTU, University Hospital of Cleveland, Cleveland, OH, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

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 NCT00270205 on ClinicalTrials.gov