Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
763 participants
INTERVENTIONAL
2004-02-29
2007-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Despite the results of the 2NN study, question remains whether the comparability of NVP and EFV is maintained over a longer period of follow-up. Therefore, this study is designed to assess the durability of the efficacy of the regimens used in the 2NN study.
In the initial CHARM study, the effect of adding nevirapine and/or hydrea to a triple NRTI regimen (trizivir i.e. abacavir, lamivudine and zidovudine) in terms of efficacy and tolerability was investigated in anti retroviral naïve patients. The primary endpoint was treatment failure and follow up was 72 weeks. A total of 229 patients were included. The use of hydrea was prematurely stopped because adding hydrea significantly contributed to treatment failure through enhancement of the toxicities associated with its use. Subjects in the nevirapine group reached a plasma HIV-1 RNA level \< 50 copies/ml quicker (log rank test p = 0.011). In addition, in an as treated analysis only 16.2% of subjects adding nevirapine versus 39.5% adding no nevirapine reached the primary endpoint (p=0.027). These results resemble the findings in the ACTG A5059 study. The trizivir arm of this ACTG study was stopped, because anti-retroviral naïve subjects randomized to receive trizivir experienced virological failure earlier and more frequent than subjects who were randomized to receive either of the two other treatment regimens being evaluated in that study. The two other treatment regimens were:
1. a combination of zidovudine plus lamivudine plus efavirenz and
2. trizivir plus efavirenz.
It is desirable to obtain extended follow up data on subjects who participated in the CHARM study in order to see if the beneficial effect of adding nevirapine to trizivir continues or even increases after 72 weeks of treatment.
In addition to this main objective, another important issue regards the known association between the use of nevirapine and the occurrence of certain untoward effects, including the development of rash, clinical hepatitis and a hypersensitivity syndrome which usually presents with rash, elevated alanine aminotransferase and/or aspartate aminotransferase, eosinophilia and a host of other constitutional symptoms. The possibility that a metabolite of nevirapine might be responsible for one or the other of these events has been evaluated but could not be confirmed. Data is equivocal on whether nevirapine levels themselves are associated with these events, probably because of "noise" in the retrospective analyses that was used. Animal models would suggest, though, that supratherapeutic nevirapine levels are associated with these events. It seems reasonable to assume that there is a sub-population of people at risk for all of these events (especially hypersensitivity) based on their genetic make-up in that it is known that many patients easily tolerate significantly elevated levels of nevirapine while others may get these side effects with relatively normal levels.
To facilitate the safe administration of nevirapine to patients, this study also aims to identify a gene or genes closely associated with these events, and from that a phenotype associated with that genotype which is at increased risk.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
stavudine
lamivudine
nevirapine
efavirenz
trizivir
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
International Antiviral Therapy Evaluation Center
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joep MA Lange, MD PhD
Role: STUDY_CHAIR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Mark Bloch, MD
Role: PRINCIPAL_INVESTIGATOR
Holdsworth House General Practice
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Holdsworth House Medical Practice
Darlinghurst, , Australia
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
04IAT0035
Identifier Type: -
Identifier Source: org_study_id