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HIV Vaccine Study in HIV Positive Patients

NCT01071031 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-09-26

No results posted yet for this study

Summary

The purpose of the study is to see whether a single vaccination (injection) with the investigational HIV vaccine is safe and effective in patients who are HIV positive but have not yet begun anti-retroviral therapy. As this is an exploratory study, four different dose formulations of HIV vaccine will be investigated.

This study will evaluate whether or not the HIV vaccine is able to reduce the HIV viral load (number of HIV virus particles in the blood) and increase or slow the decline in CD4 T cell count.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

HIV-v (Low Dose)

Low Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences) with water for injection or adjuvant Administration: A single subcutaneous injection

BIOLOGICAL

HIV-v (High Dose)

High Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences with water for injection or adjuvant Administration: A single subcutaneous injection

BIOLOGICAL

HIV-v (Control)

Adjuvant only or Water for injection only Administration: A single subcutaneous injection

Sponsors & Collaborators

  • PepTcell Limited

    lead INDUSTRY

Principal Investigators

  • Marta Boffito, MD PhD · St Stephen's Aids Trust

  • Stuart Robinson · PepTcell Limited

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United Kingdom

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 NCT01071031 on ClinicalTrials.gov