This trial is no longer enrolling. This may mean the trial is fully enrolled, or that enrolment in the trial has been halted or suspended. You cannot enrol in this trial.
About this trial
This is a trial for a new antiretroviralA medication or other substance which is active against retroviruses such as HIV. called apricitabine - an experimental(Of a drug) Not licensed for use in humans, or as a treatment for a particular condition. Experimental drugs are studied in clinical trials to determine their safety and efficacy, and are sometimes made available via Special Access Schemes prior to their approval. nucleoside reverse transcriptase inhibitor for people who are resistantHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. to other NRTIs, and who have the M184V mutation.
This study will look at how safe, easy to take and effective apricitabine is in people who are resistant to 3TC. If successful, it is hoped to use it as an alternative.
Background information
Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs or "nukes") are considered the all-important backbone for treating HIV and most peoples' regimens include at least one drug from this class.
The more commonly used NRTIs include lamivudine (3TC), zidovudine (AZT), didanosine (ddI) and abacavir.
After a while, people may become resistantHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. to NRTIs and develop mutations, especially the M184V mutation. People with the M184V mutation can sometimes continue to take lamivudine (3TC) with some effect but there isn't another similar drug to replace it.
In a Phase IIA smaller clinical trial designed to establish whether a drug is effective. Phase II studies are conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. If there is evidence that the drug is effective, a Phase III study is undertaken, with a larger number of participaants, to confirm this. study, apricitabine (in combination with other HIV drugs) showed that it was effective in people who had the M184V mutation as well as being safe and easy to take.
| Official title: | A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of apricitabine versus lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase |
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| What is this trial studying? | New drug – apricitabine |
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| Start date: | June 2008 This may be the proposed or expected start date for trials which have not yet started. |
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| How many participants will this trial enrol? | 1014 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 take the trial drug for 48 weeks. Following the conclusion of the trial, participants will be followed up for a further 4 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? | Your HIV s100 prescriber may arrange compassionate access if you are eligible
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| Tags: | Apricitabine, NRTI |
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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 taken HIV treatments in the past
- Viral load at least 2000 copies/ml
- Shown a resitance to other NRTIs and carry the M184V mutation
- Currently taking lamivudine (3TC) or emtricitabine (FTC)
You
will not be eligible to participate in this trial if you meet any of the following criteria:
- You must not have hepatitis B (HBV)
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.
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