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 studyA 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 looking at the safety, tolerability 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. of elvitegravir, 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. integrase inhibitor, boosted with ritonavir.
They are comparing the drug to the recently approved integrase inhibitor - raltegravir.
People who are treatment experienced will be given either drug with a background regimen including another protease inhibitorA type of anti-HIV drug that works by preventing the production of an enzyme, protease, that HIV needs to replicate..
| Official title: | A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults |
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| What is this trial studying? | New drug – elvitegravir (GS-9137) |
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| Start date: | August 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? | 700 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. |
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| Links to further information: | |
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| Tags: | Elvitegravir, integrase inhibitor, raltegravir |
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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
- Currently taking HIV treatments
- Have taken HIV treatments in the past
- 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.
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