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New Era Study: Treatment With Multi Drug Class (MDC) HAART in HIV Infected Patients

NCT00908544 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-08-28

Study results available
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Summary

This is a multi-center, open-label, non-randomized proof-of-concept trial. Two cooperating HIV-specialized centres represented by Dr. med. Hans Jaeger and Prof. Dr. Johannes Bogner are planning to perform an IIT (investigator initiated trial) with the goal to eradicate HIV in N=40 HIV-infected patients with either primary infection or chronic infection and successful HAART (Highly Active Antiretroviral Treatment) of several years.

All patients will be started on a multi-drug HAART including two Nucleoside-Reverse-Transcriptase-Inhibitors (NRTI´s), one Protease-Inhibitor (PI), a CCR5-inhibitor and an Integrase-Inhibitor (INI). Decay of viral reservoirs like latently HIV-infected CD4+ T-cells will be monitored over time.

Conditions

  • HIV Infections

Interventions

OTHER

PHI-patients

Treatment initiation with multi drug class (MDC) HAART. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir

OTHER

CHI-patients

Treatment intensification of PI-based HAART with Maraviroc and Raltegravir. 2 NRTI + 1 PI/r + Maraviroc + Raltegravir

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • AbbVie

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • German Center for Infection Research

    collaborator OTHER

  • MUC Research GmbH

    lead OTHER

Principal Investigators

  • Hans Jaeger, MD · MUC Research GmbH

  • Johannes Bogner, Prof., MD · University Munich, University Hospital, Dept. of Infectious Diseases,

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-05-15
Primary Completion
2018-04-03
Completion
2018-05-31

Countries

  • Germany

Study Locations

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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 NCT00908544 on ClinicalTrials.gov