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Raltegravir Switch for Toxicity or Adverse Events

NCT00958100 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-02-04

No results posted yet for this study

Summary

This study aims to verify the persistent control of the virus replication at 48 weeks after the simplification to tenofovir + emtricitabine + raltegravir or to lamivudine+abacavir+raltegravir in patients with optimal virological suppression without any virological failure to previous combined antiretroviral therapies needing a therapeutic switch for toxicity related issues or adverse events.

Conditions

  • HIV/AIDS
  • Antiretroviral Therapy
  • HIV Infections

Interventions

DRUG

tenofovir emtricitabine raltegravir

switch from current antiretroviral regimen to raltegravir with tenofovir/emtricitabine as backbone

DRUG

Lamivudine Abacavir Raltegravir

Switch from current antiretroviral regimen to raltegravir with abacavir/lamivudine as backbone

DRUG

Abacavir free

Patients will receive raltegravir with tenofovir/emtricitabine; data will be added to those of Tenofovir Emtricitabine Raltegravir arm in a separate longitudinal analysis comparing data at baseline and at 48 weeks. In this separate analysis, data will not be compared to those obtained from the Lamivudine Abacavir Raltegravir arm. The number of patients in this arm is not pre-established.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT00958100 on ClinicalTrials.gov