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

December 19, 2006
October 30, 2008
August 2004
July 2006   (final data collection date for primary outcome measure)
Proportion of patients with plasma viral load below 50 copies/mL . [ Time Frame: after 48 weeks of follow-up ] [ Designated as safety issue: No ]
Proportion of patients with plasma viral load below 50 copies/mL after 48 weeks of follow-up.
Complete list of historical versions of study NCT00415090 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).
  • Evolution of the CD4 lymphocyte count at 48 weeks.
  • Pattern of mutations associated with resistance in patients presenting virological failure.
  • Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.
  • Incidence of AIDS-defining events (CDC C events, 1993).
  • Mortality by any cause.
Not Provided
Not Provided
 
Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Nevirapine
Switch one of ARV drugs to Nevirapine
Other Name: Switch one of ARV drugs to Nevirapine
  • No Intervention: 1
    Follow with same ARV treatment
  • Experimental: 2
    Switch one of ARV drugs to Nevirapine
    Intervention: Drug: Nevirapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00415090
TRIMUNE
No
Hospital San Jaime de Calella
Hospital de Calella
Not Provided
Principal Investigator: Josep Mª Llibre, MD,PhD Hospital Sant Jaume de Calella
Hospital de Calella
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP