This trial is concluded. This means the trial has been completed. The results of the trial are summarised in the 'results' section of this page. You cannot enrol in this trial.
About this trial
This study is looking at two versions of the same drug - nevirapine - and comparing the effectiveness(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. and safety of one that releases the drug over a long period against one that does so immediately.
It's a double-blindA clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study./double-dummy trial so no-one knows who's on which version of the drug - the slow release one or the immediate release one. Everyone will be put on the same background regimen - Truvada (tenofovir-emtracitabine).
You need to be treatment naive to enrol.
Background information
Nevirapine is one of four non-nucleoside reverse transcriptase inhibitors (NNRTIs) available in Australia (efavirenz, delarvirdine and etravirine are the other 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. approved drugs).
The NNRTIs work by binding directly to the reverse transcriptase enzyme, thereby interfering with its activity.
When HIV infects a CD4 cell in a person's body, it copies its own genetic code into the cell's DNA. In this way, the cell is then 'programmed' to create new copies of HIV. HIV's genetic material is in the form of RNA. In order for it to infect CD4 cells, it must first convert its RNA into DNA. HIV's reverse transcriptase enzyme is needed to perform this process.
NNRTIs, also known 'non-nukes' attach themselves to reverse transcriptase and prevent the enzyme from converting RNA to DNA. In turn, HIV's genetic material cannot be incorporated into the healthy genetic material of the cell, and prevents the cell from producing new virusA small infective organism which is incapable of reproducing outside a host cell..
All drugs in this family have similar side effectAn unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time. profiles - rash being the most common (see Nevirapine Toxicogenomics Study).
| Official title: | A Randomised, Double Blind, Double Dummy, Parallel Group, Active Controlled Trial to Evaluate the Antiviral Efficacy of 400 mg QD Nevirapine Extended Release Formulation in Comparison to 200 mg BID Nevirapine Immediate Release in Combination With Truvada? in Antiretroviral Therapy Naive HIV-1 Infect |
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| What is this trial studying? | Treatment strategy – nevirapine, Truvada |
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| How many participants will this trial enrol? | 1033 The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic. |
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| How long is this trial planned to go for? | Participants in this trial will be asked to follow the treatment strategy for 48 weeks. |
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| Links to further information: | |
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| Related trials: | |
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| Can I access this treatment other than by enrolling in this trial? | Nevirapine in its standard form is an approved drug.
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| Tags: | liver disorders, optimised background regimens, treatment side effects |
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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
- Have never taken HIV treatments
- CD4 count between 50 and 400 cells/mm3
- Viral load at least 1000 copies/ml
You
will not be eligible to participate in this trial if you meet any of the following criteria:
- Have active hepatitis B or C
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:
August 2010 update:
Interim results from the VERxVE study were presented last month at the 18th International AIDS Society (IAS) conference in Vienna, Austria, and showed that once daily nevirapine extended release (XR) formulation (400mg QD)
Viramune(r) is non-inferior to the currently used twice daily immediate release (200mg BID) Viramune(r) (IR) through 48 weeks.
The 400mg QD nevirapine extended release formulation (Viramune(r) XR) demonstrated adequate trough drug exposure through 48 weeks, and efficacy(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. was consistent across gender, baseline1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values. viral loadA measurement of the quantity of HIV RNA in the blood. Viral load blood test results are expressed as the number of copies (of HIV) per milliliter of blood plasma. and country of origin. Both formulations demonstrated a similar adverse event profile and no new side effects were identified.
The primary endpointOverall outcome that a clinical trial protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. for VERxVE was confirmed virological response through 48 weeks of treatment, with response defined as a viral load of <50 copies/mL measured on two consecutive occasions at least two weeks apart prior to or at week 48 and without subsequent rebound or change of therapy prior to or at week 48. VERxVE follow-up is currently planned to continue for a total of
144 weeks.
April 2012 Update
On the 1 April, Viramune XR (Nevirapine extended release) was listed on the 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., as a highly specialised drug provided under Section 100 of the National Health Act.
Viramune XR is the new ‘once a day’ formulation of Nevirapine which supersedes Viramune IR or ‘twice a day’ formulation.
See attachment below for full report
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