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

NCT00437684 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

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 HIV/HCV coinfected patients.

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

Conditions

  • HIV Infections
  • Hepatitis C

Interventions

DRUG

LPV/r

200/50 mg 2 cpr bid monotherapy

DRUG

PEG-IFNa 2a

PEG-IFNa 2a 180 mcg/week

DRUG

Ribavirin

Ribavirin 1-1.2 g/day

DRUG

NUCS

Nucleoside Reverse Transcriptase Inhibitors

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

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 NCT00437684 on ClinicalTrials.gov