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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Keywords

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Nevirapine Antiretroviral treatment Triple nucleoside therapy HIV Treatment Experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Follow with same ARV treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Switch one of ARV drugs to Nevirapine

Group Type EXPERIMENTAL

Nevirapine

Intervention Type DRUG

Switch one of ARV drugs to Nevirapine

Interventions

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Nevirapine

Switch one of ARV drugs to Nevirapine

Intervention Type DRUG

Other Intervention Names

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Switch one of ARV drugs to Nevirapine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Hospital San Jaime de Calella

Principal Investigators

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Josep Mª Llibre, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sant Jaume de Calella

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Spain

Other Identifiers

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TRIMUNE

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

1

2

Nevirapine

Interventions

Nevirapine

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Hospital de Calella

Responsible Party

Principal Investigators

Josep Mª Llibre, MD,PhD

Locations

Hospital.Universitari Germans Trias i Pujol

Centre Penitenciari Brians

Hopsital de Sant Pau

Hospital Vall d'Hebron

Hospital Clínic i Provincial de Barcelona

Hospital Sant Jaume de Calella

Centre Penitenciari Homes

Hospital General de Granollers

Centre Penitenciari Quatre Camins

Hospital de Bellvitge

Mutua de Terrassa

Hospital La Candelaria

Hospital Clínico San Carlos de Madrid

Hospital Universitari Sant Joan de Reus

Hospital La Fe de Valencia

Hospital Miguel Servet

Hospital de Tortosa

Countries

Other Identifiers

TRIMUNE