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Immunization With HIV-1 Peptides in Adjuvant for Treatment of Patients With Chronic HIV-infection

NCT01009762 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2014-03-27

Study results available
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Summary

Treatment: Immunization with a peptide-mix of 17 Clusters of Differentiation number 8 (CD8) T cell minimal epitopes and 3 Clusters of Differentiation number 4 (CD4) T cell epitopes and a new adjuvant (CAF01). The vaccine should induce cellular immunity against human immuno-deficiency virus type-1 (HIV-1).

Target group: Untreated healthy individuals with chronic HIV-1 infection who are not in antiretroviral treatment.

Purpose: The primary purpose is to evaluate tolerability and safety of the vaccine.

The secondary purpose is to evaluate the clinical effect of the vaccination treatment as measured by induction of new T cell immunity, lowering of HIV-1 ribonucleic acid (RNA) viral load in plasma, and improvement in the patient CD4 lymphocyte blood counts.

Design: The experiment is designed as a single-blinded, placebo-controlled phase 1 clinical trial in HIV-1 infected individuals in Denmark.

Numbers of individuals: 20 fully evaluable HIV-1-infected patients should enter the study (15 vaccine treated and 5 placebo(saline) treated controls).

The hypothesis is that a redirection of cytotoxic T lymphocyte (CTL) immunity to selected relatively immune silent (subdominant) but conserved CTL targets on multiple sites in HIV-1 could provide a better immune control of the virus replication. This could result in lowering of viral load thereby prolonging the time to antiretroviral therapy.

Conditions

  • HIV INFECTIONS

Interventions

BIOLOGICAL

peptide vaccine (AFO-18)

18 Peptides (250 ug of each peptide) in Adjuvant CAF01 (= 625/125 ug DDA/TDB), i.m. injection week 0, 2, 4, 8.

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Hvidovre University Hospital

    collaborator OTHER

  • Ministry of the Interior and Health, Denmark

    collaborator OTHER_GOV

  • Gitte Kronborg

    lead OTHER

Principal Investigators

  • Gitte Kronborg, MD · Hvidovre University Hospital

  • Anders Fomsgaard, MD · Statens Serum Institut

  • Jan Gerstoft, MD · University Hospital Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Denmark

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 NCT01009762 on ClinicalTrials.gov