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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415090
• Other study ID #: TRIMUNE
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2006
• Last updated: October 30, 2008
• Start date: August 2004
• Est. completion date: July 2006

Study information

• Verified date: October 2008
• Source: Hospital de Calella
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nevirapine
Switch one of ARV drugs to Nevirapine

Locations

Country	Name	City	State
Spain	Hospital.Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Centre Penitenciari Brians	Barcelona
Spain	Centre Penitenciari Homes	Barcelona
Spain	Hopsital de Sant Pau	Barcelona
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital Sant Jaume de Calella	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Centre Penitenciari Quatre Camins	Granollers	Barcelona
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Clínico San Carlos de Madrid	Madrid
Spain	Hospital Universitari Sant Joan de Reus	Reus	Tarragona
Spain	Hospital La Candelaria	Tenerife	Canarias
Spain	Mutua de Terrassa	Terrassa	Barcelona
Spain	Hospital de Tortosa	Tortosa
Spain	Hospital La Fe de Valencia	Valencia
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Calella

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with plasma viral load below 50 copies/mL .		after 48 weeks of follow-up	No
Secondary	Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).		During the 48 weeks of follow-up.	No
Secondary	Evolution of the CD4 lymphocyte count at 48 weeks.		during 48 weeks of follow-up	No
Secondary	Pattern of mutations associated with resistance in patients presenting virological failure.		When there is a virological failure	No
Secondary	Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.		during the 48 weeks of follow-up	Yes
Secondary	Incidence of AIDS-defining events (CDC C events, 1993).		during the 48 weeks of follow-up	Yes
Secondary	Mortality by any cause.		during the 48 weeks of follow-up	Yes