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Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

NCT01900015 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-07-25

No results posted yet for this study

Summary

Primary Objective:

To compare the impact of switching from efavirenz (EFV) plus two nucleoside analogs to rategravir (RAL) plus two nucleoside analogs versus keeping the same antiretroviral regimen on hepatic steatosis (HS) as measured by the controlled attenuation parameter (CAP) among HIV/HCV-coinfected patient.

Secondary Trial Objective:

1. To compare the proportion of HIV/HCV-coinfected patients with one category decrease in the grade of HS between patients continuing with EFV plus two nucleoside analogs and those switching from EFV plus two nucleoside analogs to RAL plus two nucleoside analogs.
2. To evaluate the proportion of patients who maintain viral control (HIV RNA \< 50 copies/mL) after switching.

Design:

Open-label, randomized clinical trial to evaluate safety (phase IV)

Condition:

HIV and HCV coinfection.

Intervention:

Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.

Conditions

  • HCV Coinfection
  • HIV Infection

Interventions

DRUG

Raltegravir

Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.

DRUG

Efavirenz

Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.

Sponsors & Collaborators

  • Juan Macías

    lead OTHER_GOV

Principal Investigators

  • Juan Macías, MD, PhD · Infectious Diseases and Microbiology Unit. Hospital Universitario de Valme. Servicio Andaluz de Salud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-03
Primary Completion
2017-01-17
Completion
2017-01-17

Countries

  • Spain

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 NCT01900015 on ClinicalTrials.gov