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

This study has been completed.
Sponsor:
Information provided by:
Hospital de Calella
ClinicalTrials.gov Identifier:
NCT00415090
First received: December 19, 2006
Last updated: October 30, 2008
Last verified: October 2008
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors

Resource links provided by NLM:


Further study details as provided by Hospital de Calella:

Primary Outcome Measures:
  • Proportion of patients with plasma viral load below 50 copies/mL . [ Time Frame: after 48 weeks of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Evolution of the CD4 lymphocyte count at 48 weeks. [ Time Frame: during 48 weeks of follow-up ] [ Designated as safety issue: No ]
  • Pattern of mutations associated with resistance in patients presenting virological failure. [ Time Frame: When there is a virological failure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of AIDS-defining events (CDC C events, 1993). [ Time Frame: during the 48 weeks of follow-up ] [ Designated as safety issue: Yes ]
  • Mortality by any cause. [ Time Frame: during the 48 weeks of follow-up ] [ Designated as safety issue: Yes ]

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
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 Name: Switch one of ARV drugs to Nevirapine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415090

Locations
Spain
Hospital.Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital General de Granollers
Granollers, Barcelona, Spain, 08400
Centre Penitenciari Quatre Camins
Granollers, Barcelona, Spain, 08430
Hospital de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital La Candelaria
Tenerife, Canarias, Spain, 38010
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain, 43201
Hospital Sant Jaume de Calella
Barcelona, Spain, 08370
Hopsital de Sant Pau
Barcelona, Spain, 08025
Centre Penitenciari Brians
Barcelona, Spain, 08009
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Centre Penitenciari Homes
Barcelona, Spain
Hospital Clínico San Carlos de Madrid
Madrid, Spain, 28040
Hospital de Tortosa
Tortosa, Spain, 43500
Hospital La Fe de Valencia
Valencia, Spain, 46009
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hospital de Calella
Investigators
Principal Investigator: Josep Mª Llibre, MD,PhD Hospital Sant Jaume de Calella
  More Information

No publications provided

Responsible Party: Hospital San Jaime de Calella
ClinicalTrials.gov Identifier: NCT00415090     History of Changes
Other Study ID Numbers: TRIMUNE
Study First Received: December 19, 2006
Last Updated: October 30, 2008
Health Authority: Spain: Ministry of Health

Keywords provided by Hospital de Calella:
Nevirapine
Antiretroviral treatment
Triple nucleoside therapy
HIV
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nevirapine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014