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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00415090
Recruitment Status : Completed
First Posted : December 22, 2006
Last Update Posted : October 31, 2008
Information provided by:
Hospital de Calella

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Nevirapine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Substitution by Nevirapine in HIV-1 Infected Patients on Triple Treatment of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors
Study Start Date : August 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Proportion of patients with plasma viral load below 50 copies/mL . [ Time Frame: after 48 weeks of follow-up ]

Secondary Outcome Measures :
  1. 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. ]
  2. Evolution of the CD4 lymphocyte count at 48 weeks. [ Time Frame: during 48 weeks of follow-up ]
  3. Pattern of mutations associated with resistance in patients presenting virological failure. [ Time Frame: When there is a virological failure ]
  4. 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 ]
  5. Incidence of AIDS-defining events (CDC C events, 1993). [ Time Frame: during the 48 weeks of follow-up ]
  6. Mortality by any cause. [ Time Frame: during the 48 weeks of follow-up ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00415090

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
Centre Penitenciari Brians
Barcelona, Spain, 08009
Hopsital de Sant Pau
Barcelona, Spain, 08025
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Sant Jaume de Calella
Barcelona, Spain, 08370
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
Principal Investigator: Josep Mª Llibre, MD,PhD Hospital Sant Jaume de Calella

Responsible Party: Hospital San Jaime de Calella Identifier: NCT00415090     History of Changes
Other Study ID Numbers: TRIMUNE
First Posted: December 22, 2006    Key Record Dates
Last Update Posted: October 31, 2008
Last Verified: October 2008

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers