This trial is concluded. This means the trial has been completed. When the results of the trial have been made public, they will be summarised in the 'outcomes' section of this page. You cannot enrol in this trial.
About this trial
It is desirable to obtain extended follow up data on subjects who participated in the 2NN study and the CHARM study in order to see if the beneficial effect of using nevirapine continues up to 144 weeks of treatment.
Background information
The 2NN study was the first large randomised trialA clinical trial in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. comparing combinations containing two nucleoside reverse transcriptase inhibitors (NRTIs) for people with longterm HIV who had never treated before. The two NRTIs were d4T and 3TC and they were given with either neviripine once-a-day, neviripine twice-a-day, efavirenz or the combination of nevirapine and efavirenz.
Results of the 2NN study:
- There were no significant differences
These results contrast with previous cohortIn epidemiology, a group of individuals with some characteristics in common. A cohort study is a special kind of clinical trial which looks at a treatment or treatment strategy in a cohort of people. studies which showed better results for those starting with nevirapine compared to those starting with efavirenz. That's why this follow-up study continued to see if results changed over a longer time.
In the initial CHARM study, the effect of adding nevirapine and/or hydrea to a triple NRTI regimen in treatment naïve patients was investigated . The triple NRTI regimen used was Trizivir (abacavir, lamivudine and zidovudine).
Results of the Charm study:
- The use of hydrea was prematurely stopped because its toxicities contributed to treatment failure
- The nevirapine group reached undetectable viral loads quicker
- Only 16.2% of subjects adding nevirapine versus 39.5% adding no nevirapine reached the primary endpointOverall outcome that a clinical trial protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death..
- The trizivir arm was stopped because those receiving trizivir experienced virological failure earlier and more frequently than those who weren't.
It was desirable to obtain extended follow up data on those 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.
Another important issue is the known association between nevirapine and certain side effects including rash, clinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. hepatitis and a hypersensitivity syndrome. 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. We know that many patients easily tolerate significantly elevated levels of nevirapine while others may get these side effects with relatively normal levels.
To help the safe administration of nevirapine to people with HIV, this study also aims to identify a gene or genesThe most basic unit of genetic information. closely associated with these adverse events, and from that a phenotype associated with that genotype which is at increased risk.
| Official title: | A Retrospective Study to Compare the 3-Year Antiviral Efficacy of Nevirapine and Efavirenz in Combination With d4T and 3TC in 2NN Patients and of Trizivir Versus Trizivir Plus Nevirapine in CHARM Patients |
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| What is this trial studying? | Treatment strategy |
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| Start date: | February 2004 This may be the proposed or expected start date for trials which have not yet started. |
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| Links to further information: | |
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| Can I access this treatment other than by enrolling in this trial? | All drugs are currently available through PBS[Pharmaceutical Benefits Scheme] The federal government program which subsidises medication costs in Australia. Anti-HIV drugs are part of a special part of the PBS called Section 100 (S100) which is used for expensive, highly specialised drugs.
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Who can enrol in this trial?
You may be eligible to participate in this trial if you meet the following criteria:
- At least 18 years old
- Participation in the original 2NN or CHARM study
This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.
Results:
See background material for preliminary results of the 2NN and Charm studies.
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