MedTrace Logo

A Safety and Immunogenicity Study of 3 Doses of Opal Immunotherapy in HIV Infected People

NCT01123915 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-03-22

No results posted yet for this study

Summary

This phase I study is the first step to determine if Opal immunotherapy may have potential utility as a treatment for HIV. Although effective treatments for HIV infection exist, they are limited by the requirement for life-long daily treatment, cost, side effects, and the development of resistance.

There is a need for therapeutic approaches that induce or enhance T-cell immunity to control HIV disease. Overlapping Peptide-pulsed Autologous Cells (Opal) is a technique where autologous peripheral blood mononuclear cells (PBMC) or whole blood is pulsed with sets of overlapping peptides spanning whole proteins of HIV.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Opal-HIV-Gag(c) Low Dose

BIOLOGICAL

Opal-HIV-Gag(c) Medium dose

BIOLOGICAL

Opal-HIV-Gag(c) High dose

OTHER

Dimethyl Sulfoxide

Sponsors & Collaborators

  • Phillip T. and Susan M. Ragon Foundation

    collaborator UNKNOWN

  • Imperial College London

    collaborator OTHER

  • Medicines Development for Global Health

    lead OTHER

Principal Investigators

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

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
2010-05-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01123915 on ClinicalTrials.gov