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Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-HCV Therapy

NCT00437476 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-02-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in patients naive for HIV and HCV.

Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART.

Conditions

  • HIV Infections
  • Hepatitis C

Interventions

DRUG

LPV/r

Lopinavir/Ritonavir 200/50 mg 2 cpr BID monotherapy - 26 weeks (A) or 24 weeks (B)

DRUG

Nucleoside Reverse Transcriptase Inhibitors

NRTIs for 26 weeks (A) or 24 weeks (B)

DRUG

PEG-IFNa 2a

PEG-IFNa 2a 180 mcg/week (48 weeks)

DRUG

Ribavirin

Ribavirin 1-1.2 g/day (48 weeks)

Sponsors & Collaborators

Principal Investigators

  • Adriano Lazzarin, MD · IRCCS San Raffaele Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • Italy

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 NCT00437476 on ClinicalTrials.gov