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Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients

NCT01019551 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2013-06-13

No results posted yet for this study

Summary

Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral therapy plus immunomodulation

Conditions

  • HIV-1 Infection

Interventions

DRUG

ART Intensification

Current ART regimen plus raltegravir and maraviroc Raltegravir : 400 mg PO BID for 56 weeks Maraviroc : 150, 300 or 600 mg PO BID depending on concomitant ART treatment, for 56 weeks

BIOLOGICAL

Immunomodulation

Starting at Week 8, 1 cycle of 3 injections (1 per week) of recombinant human Interleukin-7 (r-hIL-7 / CYT107) at a 20 µg/kg dose.

Sponsors & Collaborators

  • Cytheris SA

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Objectif Recherche Vaccins SIDA

    lead OTHER

Principal Investigators

  • Christine KATLAMA, MD · Groupe Hospitalier Pitié-Salpêtrière

  • Steven DEEKS, MD · University of California, San Francisco

  • François LECARDONNEL, MSc · ORVACS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-07-31
Completion
2013-02-28

Countries

  • France
  • Italy
  • Spain
  • United Kingdom

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 NCT01019551 on ClinicalTrials.gov