A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects - NCT00951015-94115 (Clinical Trial 304471)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy304471.aspx
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| City: |
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San Francisco |
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State:
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CA |
| Zip Code: |
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94115 |
| Conditions: |
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HIV Infection - HIV-1 Infection |
| Purpose: |
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This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal
once daily dose of GSK1349572 from a range of doses for future evaluation.
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| Study summary: |
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This Phase IIb study in HIV-infected antiretroviral naive adult subjects will include a
dose-ranging evaluation of GSK1349572 10mg, 25mg and 50mg once daily blinded doses and a
control arm of open label efavirenz 600mg once daily. Background ART for all study subjects
will be chosen by the investigators and will be either Truvada or Epzicom/Kivexa. Data from
the three doses of GSK1349572 will be compared on the basis of antiviral activity,
safety/tolerability and pharmacokinetics over 16-24 weeks.
Several planned interim analyses will evaluate data in real time; any doses considered
inferior will be dropped and subjects on those doses of GSK1349572 will have the option to
switch to either the highest dose still under investigation or the selected dose. Subjects
will be able to remain in the study, unless they reach a stopping criterion, for at least 96
weeks. |
| Criteria: |
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Inclusion Criteria:
- HIV-1 infected male or female adults at least 18 years of age. Women capable of
becoming pregnant must use appropriate contraception during the study (as defined by
the protocol);
- HIV-1 infection with a screening plasma HIV-1 RNA greater than or equal to
1000copies/mL;
- CD4+ cell count greater than or equal to 100cells/mm3 (or higher as local guidelines
dictate);
- ART-naive (less than or equal to 10 days of prior therapy with any antiretroviral
agent). Any previous exposure to an HIV integrase inhibitor other than GSK1349572
will be exclusionary.
- No evidence of viral resistance to any antiretroviral drug indicative of primary
transmitted resistance at screening;
- Able to understand and comply with protocol requirements;
- Able to provide written informed consent prior to screening;
- French subjects: In France, a subject will be eligible for inclusion in this study
only if either affiliated to or a beneficiary of a social security category.
Note: Subjects starting abacavir as part of the NRTI backbone must have been screened and
be negative for the HLA-B*5701 allele.
Exclusion Criteria:
- Any pre-existing or serious mental or physical disorder which could compromise
ability to comply with the protocol or compromise subject safety;
- Women who are pregnant or breastfeeding;
- An active AIDS-defining condition at the screening visit;
- Previous participation in an experimental drug and/or vaccine trial(s) within 30 days
or 5 half-lives;
- History of clinically relevant pancreatitis or hepatitis within the previous 6
months, including HBsAg positive result. Asymptomatic HCV infection will not be
exclusionary, however subject who will require HCV therapy during the trial should be
excluded. Any subject with a history of liver cirrhosis with or without hepatitis
viral co-infection will be excluded.
- Any condition which could interfere with the absorption, distribution, metabolism or
excretion of the drug;
- Any acute or Grade 4 laboratory abnormality at screening;
- History of upper gastrointestinal bleed and/or subjects with active peptic ulcer
disease;
- Estimated creatinine clearance <50 mL/min;
- Alanine aminotransferase (ALT) greater than or equal to 5 times ULN;
- Alanine aminotransferase (ALT) greater than or equal to 3xULN and bilirubin greater
than or equal to 1.5xULN (with >35% direct bilirubin);
- Lipase greater than or equal to 3xULN;
- Hemoglobin < 100 g/L(10 g/dL);
- History of allergy to the study drugs or their components or drugs of their class;
- Treatment with radiation therapy, cytotoxic chemotherapeutic agents, any agents with
activity against HIV-1 or immunomodulators within 28 days prior to screening;
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to screening;
- History of protocol-defined cardiac diseases;
- Personal or family history of prolonged QT syndrome;
- Any clinically significant finding, as specified in the protocol, on
electrocardiograph (ECG);
- Significant blood loss in excess of 500 mL within a 56 day period prior to screening
visit;
- Immunization within 30 days prior to first dose of investigational product;
- French subjects: The subject has participated in any study using an investigational
drug during the previous 60 days or 5 half-lives, or twice the duration of the
biological effect of the experimental drug or vaccine - whichever is longer, prior to
screening for the study or the subject will participate simultaneously in another
clinical study. |
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| Study is available at: |
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GSK Investigational Site
San Francisco, CA 94115
United States
Primary Contact:
US GSK Clinical Trials Call Center
Phone: 877-379-3718 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 17, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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