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.
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.
Nevirapine is one of four non-nucleoside reverse transcriptase inhibitors (NNRTIs) available in Australia (efavirenz, delarvirdine and etravirine are the other PBS 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 virus.
All drugs in this family have similar side effect profiles - rash being the most common (see Nevirapine Toxicogenomics Study).
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
tx_strategy – nevirapine, Truvada
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.)
Participants in this trial will be asked to follow the treatment strategy for 48 weeks.
You may be eligible to participate in this trial if you meet the following criteria:
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.
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, visit the NAPWA website for background information on participating in clinical research.
Contact NAPWA if you have any questions or comments about this trial.