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 SINGLE study is designed to compare the 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. and safety of a new multi-class formulation called 572-Trii (dolutegravir/abacavir/lamivudine) with that of Atripla (efavirenz/tenofovir/emtricitabine).
The trial's primary objective is to demonstrate the antiviralA medication or substance which is active against one or more viruses. May include anti-HIV drugs, but these are more accurately termed antiretrovirals. activity of 572-Trii once-daily therapy compared to Atripla over 48 weeks. Secondary objectives include the assessment of the tolerability, long-term safety, and antiviral and immunologic activity of 572-Trii once-daily compared to EFV/TDF/FTC over 96 weeks.
Investigators will also evaluate viral resistanceHIV which has mutated and is less susceptible to the effects of one or more anti-HIV drugs is said to be resistant. in people who experience virologic failure.
Background information
Dolutegravir or 572 is an investigational(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 manufactured by ViiV Healthcare.
| Official title: | A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects |
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| What is this trial studying? | New drug – integrase inhibitors |
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| Start date: | February 2011 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? | 800 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 48 weeks. |
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| Links to further information: | |
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| Related trials: | |
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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
- Viral load at least 1000 copies/ml
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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