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UK-453, 061

Clinical trial • Enrolling • 24 March 2009
This trial is enrolling now. Depending on eligibility and available places in your area, you may be able to enrol in this trial.

About this trial

UK-453, 061 is a second generation NNRTI (or non-nuke).

In Phase IA clinical trial designed to establish whether an experimental drug is safe for humans to take. Phase I studies determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and look for early evidence of effectiveness; these studies may include either people with HIV, HIV-negative volunteers, or both trials it proved to be effective against mutations of HIV which were resistantHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. to first generation NNRTIs, like nevirapine and efavirenz.

In this 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. trial they want to test different doses of the drug to see which is the safest and most effective. They also want to compare how well it works against efavirenz, so some of the people in the study will receive UK-453, 061 plus Truvada and the others will receive efavirenz plus Truvada.

NB: Truvada contains the 2 nucleosides tenofovir and emtricitabine.

Background information

NNRTIs form the backbone of many people's treatment regimens. Currently there are only three approved drugs available in this class - nevirapine and efavirenz being the two most prescribed - and people often develop resistanceHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. to one or both of them.

Other 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. NNRTIs also being trialed include rilpivirine and etravirine.

Official title:A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1
What is this trial studying?New drug – efavirenz, Truvada, UK-453,061
Start date:February 2009

This may be the proposed or expected start date for trials which have not yet started.

How many participants will this trial enrol?189

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.

How long is this trial planned to go for?Participants in this trial will be asked to take the trial drugs for 96 weeks.
Links to further information:
Can I access this treatment other than by enrolling in this trial?

Expanded accessBefore a drug has been approved, manufacturers often provide the drug free of charge to people who cannot participate in a clinical trial and who meet certain criteria under a Special Access Scheme (SAS). is available which means anyone who drops out of the trial can still receive the drug.

Tags:drug resistance, NNRTI

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
  • HIV-positive
  • CD4 count at least 200 cells/mm3
  • Viral load at least 1000 copies/ml

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.

If you are interested in enrolling in this trial

Before making the decision to participate in any clinical trial, NAPWA recommends that you discuss the potential benefits and risks of participation with your treating doctor. Your doctor can also provide advice about your eligibility to participate in the trial.

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.

  • You can print this page to take it with you to the doctor – just use your browser's 'print' function.
  • Before making the decision to participate in any clinical research, read our background information.
  • Email NAPWA if you have any questions or comments about this trial
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This Clinical trial was first published on 24 March 2009 — more than one year ago.

While the content of this clinical trial was checked for accuracy at the time of publication, NAPWA recommends checking to determine whether the information is the most up-to-date available, especially when making decisions which may affect your health.

This article may contain medical information. NAPWA makes every reasonable effort to ensure the information on this website is accurate, reliable and up-to-date, including obtaining technical reviews by medically-qualified reviewers, however the authors of information on this website are not qualified to give medical advice, except where explicitly stated.

The content of this website is intended to support, not replace, the relationship between people living with HIV/AIDS and their medical advisers, and is not intended as a substitute for medical advice.

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