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Immunogenicity and Safety Trial of the HIV-1 Tat Vaccine

NCT00751595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2016-03-04

No results posted yet for this study

Summary

The study is a randomized, open label, phase II clinical trial directed at evaluating the immunogenicity (as a primary end-point) and the safety (as a secondary end-point), of the recombinant HIV-1 Tat vaccine in HIV-1 infected adult subjects, anti-Tat antibody negative, HAART-treated with chronic suppressed HIV-1 infection, CD4+ T cell counts \>= 200 cells/microliter, levels of plasma viremia \< 50 copies/ml in the last 6 months prior to the screening and without a history of virologic rebound. The immunogenicity of 3 or 5 immunizations of the two different vaccine doses (7.5 and 30 micrograms) of the Tat vaccine has been evaluated.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Tat protein

Biologically active recombinant Tat protein

Sponsors & Collaborators

  • Barbara Ensoli, MD

    lead OTHER

Principal Investigators

  • Barbara Ensoli, MD, PhD · National AIDS Center (CNAIDS), Istituto Superiore di Sanita', Rome, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-06-30
Completion
2012-12-31

Countries

  • Italy

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 NCT00751595 on ClinicalTrials.gov