MedTrace Logo

Immune Responses in Patients Treated With Raltegravir

NCT00785967 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2015-04-14

No results posted yet for this study

Summary

Hypothesis: Treatment with raltegravir does not alter V(D)J recombination or immune responses to neoantigens.

A process known as V(D)J recombination is essential for developing lymphocytes and the specific functioning of the immune system. Raltegravir is the first approved drug of the new integrase inhibitor class of anti-HIV drugs. Integrase inhibitors have been shown in some studies to interfere with DNA cleavage and the activities of RAG-1/2. These studies suggest a potential to affect aspects of both B-cell and T-cell development, therefore, it is important to evaluate the potential effects that integrase inhibitors may have in clinical use. If immunoglobulin and T-cell receptor genes are altered by HIV integrase, then patient lymphocytes will fail to display normal responses to vaccinations.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

Various vaccines

VAQTA: 1.0ml IM at weeks 24 \& 48; Pneumovax 23: 0.5ml IM at screening; Td ADSORBED: 0.5ml IM at screening; phiX174 bacteriophage: 0.02ml/kg body weight IV at weeks 28, 32, 36, 40.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Christos M Tsoukas, MD, FRCPC · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT00785967 on ClinicalTrials.gov