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A Study to Compare Brachial Artery Reactivity and Cardiovascular Risk of a Treatment Simplification by Darunavir/Ritonavir (DRV/r) 800/100 mg Versus a Triple Combination Therapy Containing DRV/r in HIV-1 Infected Patients

NCT01391013 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-06-27

Study results available
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Summary

The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected participants.

Conditions

  • Human Immunodeficiency Virus 1

Interventions

DRUG

Darunavir(DRV)

Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks

DRUG

Ritonavir

Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks

DRUG

2 nucleoside reverse transcriptase inhibitors (NRTIs)

2 NRTIs will be administered as per the package inserts.

Sponsors & Collaborators

  • Janssen-Cilag S.p.A.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag S.p.A. Clinical Trial · Janssen-Cilag S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-04-30
Completion
2011-04-30

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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 NCT01391013 on ClinicalTrials.gov