Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only

October 30, 2008 updated by: Hospital de Calella

Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors

The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

RTNI (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. The presence of a smaller or greater degree of cross resistance among all RTNI is increasingly better described and acknowledged, whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited.

This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate. This therapeutic approach has demonstrated its effectiveness in clinical practice, albeit not in this scenario.

If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options.

To intensify with this proactive approach these combinations based on N/NNRTI (nucleotide analog), the NNRTI are an optimal alternative.There is vast experience with NVP in simplification/maintenance trials. In direct comparative simplification studies in patients with virological response, the response rates with NVP or EFV have shown no differences. With a relative risk (RR) of virological failure of 0.54 with regard to the continuation of PI (protease inhibitors), NVP is one of the best simplification treatment options in HIV-1-infected patients.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08009
        • Centre Penitenciari Brians
      • Barcelona, Spain, 08025
        • Hopsital de Sant Pau
      • Barcelona, Spain, 08370
        • Hospital Sant Jaume de Calella
      • Barcelona, Spain
        • Centre Penitenciari Homes
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos de Madrid
      • Tortosa, Spain, 43500
        • Hospital de Tortosa
      • Valencia, Spain, 46009
        • Hospital La Fe de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital.Universitari Germans Trias i Pujol
      • Granollers, Barcelona, Spain, 08400
        • Hospital General de Granollers
      • Granollers, Barcelona, Spain, 08430
        • Centre Penitenciari Quatre Camins
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital de Bellvitge
      • Terrassa, Barcelona, Spain, 08221
        • Mutua de Terrassa
    • Canarias
      • Tenerife, Canarias, Spain, 38010
        • Hospital La Candelaria
    • Tarragona
      • Reus, Tarragona, Spain, 43201
        • Hospital Universitari Sant Joan de Reus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.
  • Age >= 18 years.
  • Confirmed diagnosis of HIV-1 infection.
  • Viral load < 50 copies/ml over the previous six months, including at least two consecutive determinations.
  • Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.
  • Acceptance and signature of the informed consent form.

Exclusion Criteria:

  • Pregnant women or those who intend to become pregnant in the study period.
  • Having had an active infection in the previous month.
  • Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).
  • Simultaneous treatment with methadone.
  • Patients with serious hepatic dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Follow with same ARV treatment
Experimental: 2
Switch one of ARV drugs to Nevirapine
Drug: Nevirapine
Switch one of ARV drugs to Nevirapine
Other Names:
  • Switch one of ARV drugs to Nevirapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with plasma viral load below 50 copies/mL .
Time Frame: after 48 weeks of follow-up
after 48 weeks of follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).
Time Frame: During the 48 weeks of follow-up.
During the 48 weeks of follow-up.
Evolution of the CD4 lymphocyte count at 48 weeks.
Time Frame: during 48 weeks of follow-up
during 48 weeks of follow-up
Pattern of mutations associated with resistance in patients presenting virological failure.
Time Frame: When there is a virological failure
When there is a virological failure
Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.
Time Frame: during the 48 weeks of follow-up
during the 48 weeks of follow-up
Incidence of AIDS-defining events (CDC C events, 1993).
Time Frame: during the 48 weeks of follow-up
during the 48 weeks of follow-up
Mortality by any cause.
Time Frame: during the 48 weeks of follow-up
during the 48 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Calella

Investigators

  • Principal Investigator: Josep Mª Llibre, MD,PhD, Hospital Sant Jaume de Calella

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

October 31, 2008

Last Update Submitted That Met QC Criteria

October 30, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMUNE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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