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Safety and Immunogenicity of HIVAX in HIV-1 Infected Subjects

NCT01428596 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-06-09

No results posted yet for this study

Summary

This study is to test a therapeutic HIV-1 vaccine (HIVAX™) in HIV-1 infected subjects. The safety and immune responses will be studied in vaccine recipients. The anti-viral effect of HIVAX vaccine will be monitored during a 12-week treatment interruption phase.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

HIVAX

Vaccine 1.0 ml SQ lower dose (10\^8 TU) at weeks 0, 8 and 16.

BIOLOGICAL

saline solution

Saline solution 1.0 ml SQ at weeks 0, 8 and 16.

BIOLOGICAL

HIVAX

Vaccine 1.0 ml SQ higher dose (10\^9 TU) at weeks 0, 8 and 16.

Sponsors & Collaborators

  • GeneCure Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Margaret Fischl, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2020-12-31
Completion
2020-12-31

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 NCT01428596 on ClinicalTrials.gov