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Effects of Intensive cART During Acute/Early HIV Infection

NCT01154673 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-04-05

Study results available
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Summary

This trial will investigate the efficacy and safety of intensified antiretroviral treatment that includes raltegravir and maraviroc during the early stages of HIV infection. With the proven efficacy of these antiviral drugs in pre- and post-clinical trials, we would like to investigate the ability of the combination of raltegravir and maraviroc plus a standard HAART backbone to further decrease the viral load in acutely infected treated HIV infected individuals.

Conditions

  • Acute HIV Infection

Interventions

DRUG

raltegravir

Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART

DRUG

maraviroc

Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART

DRUG

emtricitabine 200mg /tenofovir 300mg

emtricitabine 200mg /tenofovir 300mg QD

DRUG

lopinavir 400 mg/ritonavir 100mg

lopinavir 400 mg/ritonavir 100mg BID

Sponsors & Collaborators

  • Unity Health Toronto

    collaborator OTHER

  • Maple Leaf Research

    collaborator OTHER

  • University of Toronto

    lead OTHER

Principal Investigators

  • Mario Ostrowski, MD · University of Toronto

  • Colin Kovacs, MD · Maple Leaf Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Canada

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 NCT01154673 on ClinicalTrials.gov