Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hospital de Calella |
---|---|
Information provided by: | Hospital de Calella |
ClinicalTrials.gov Identifier: | NCT00415090 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Nevirapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors |
Enrollment: | 28 |
Study Start Date: | August 2004 |
Study Completion Date: | July 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: No Intervention
Follow with same ARV treatment
|
|
2: Experimental
Switch one of ARV drugs to Nevirapine
|
Drug: Nevirapine
Switch one of ARV drugs to Nevirapine
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital de Tortosa | |
Tortosa, Spain, 43500 | |
Hospital Sant Jaume de Calella | |
Barcelona, Spain, 08370 | |
Hospital Clínic i Provincial de Barcelona | |
Barcelona, Spain, 08036 | |
Hospital Vall d'Hebron | |
Barcelona, Spain, 08035 | |
Hospital Clínico San Carlos de Madrid | |
Madrid, Spain, 28040 | |
Centre Penitenciari Homes | |
Barcelona, Spain | |
Centre Penitenciari Brians | |
Barcelona, Spain, 08009 | |
Hopsital de Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital La Fe de Valencia | |
Valencia, Spain, 46009 | |
Hospital Miguel Servet | |
Zaragoza, Spain, 50009 | |
Spain, Barcelona | |
Hospital General de Granollers | |
Granollers, Barcelona, Spain, 08400 | |
Mutua de Terrassa | |
Terrassa, Barcelona, Spain, 08221 | |
Hospital.Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Hospital de Bellvitge | |
Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Centre Penitenciari Quatre Camins | |
Granollers, Barcelona, Spain, 08430 | |
Spain, Canarias | |
Hospital La Candelaria | |
Tenerife, Canarias, Spain, 38010 | |
Spain, Tarragona | |
Hospital Universitari Sant Joan de Reus | |
Reus, Tarragona, Spain, 43201 |
Principal Investigator: | Josep Mª Llibre, MD,PhD | Hospital Sant Jaume de Calella |
Responsible Party: | Hospital San Jaime de Calella ( Hospital San Jaime de Calella ) |
Study ID Numbers: | TRIMUNE |
Study First Received: | December 19, 2006 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00415090 |
Health Authority: | Spain: Ministry of Health |
Nevirapine Antiretroviral treatment Triple nucleoside therapy HIV Treatment Experienced |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |