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
The main purpose of this research study is to evaluate how effective two different doses of bevirimat are at reducing the amount of HIV in the blood and what, if any, side effects there may be through 14 days of dosing.
This study will also evaluate the antiretroviralA medication or other substance which is active against retroviruses such as HIV. activity and safety of bevirimat in participants who continue with the drug as part of a combination regimen for up to 24 weeks. They also want to know how much of the drug gets into the blood stream following oral administration.
Participants in this trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. will be asked to take the trial drug as monotherapy for 14 days and as part of an optimised background regimen for up to 72 weeks.
Background information
Bevirimat, also known as MPC-4326, is a first-in-its-class maturation inhibitor.
| Official title: | A Phase II multicenter, open-label,
randomized, parallel group, study of
bevirimat (MPC-4326) in HIV-1 positive patients to evaluate the safety, efficacy, and pharmacokinetics of bevirimat administered as monotherapy for 14 days and as part of an optimized background regimen for
up to 72 weeks. |
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| What is this trial studying? | New drug – bevirimat (MPC-4326) |
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| Start date: | 18 April 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? | 32 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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| Links to further information: | |
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| Tags: | Bevirimat |
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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 at least 100 cells/mm3
- Viral load between 2000 and 500000 copies/ml
- Treatment-experienced patients must have documented evidence of genotypic resistance in their medical records (at screening) or have a resistance-associated primary mutation at screening by genotype to at least one approved antiretroviral drug. They must also be on a regimen containing at least 3 drugs which has been unchanged for at least 8 weeks prior to initial screening. Note: A washout period of at least 3 days prior to Day 1 of dosing is required.
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:
This trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. is planned to close on December 18 2009.
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