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 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 cohort 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 endpoint.
- 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, clinical 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 genes 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 |
| Start date: | February 2004 This may be the proposed or expected start date for trials which have not yet started. |
| Who can enrol in this trial? | You may be eligible to participate in this trial if you meet the following criteria:
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| Links to further information: | |
| Results: | See background material for preliminary results of the 2NN and Charm studies. |
| Can I access this treatment other than by enrolling in this trial? | All drugs are currently available through PBS |
| Keywords: | efavirenz, lamivudine, nevirapine, stavudine, Trizivir |
While NAPWA has taken every care to compile the information on this page and to keep it up-to-date, we cannot guarantee its correctness and completeness.
- Before making the decision to participate in any clinical research, read our background information.
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If you've ever participated in a clinical trial, or tried to make sense of scientific research reports, you may have found some of the specialised language confusing to say the least. This Backgrounder (from the Nov-Dec 2002 edition of Positive Living) looks at the vocabulary of clinical trials.