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View Clinical Trial (Medical Research Study)
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A Clinical Research Study for Assessing the Effectiveness of the New Integrase Inhibitor GSK1349572 in HIV-infected Persons With Prior Antiretroviral Treatment and Resistance to Raltegravir - NCT00950859-27514 (Clinical Trial 367110)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy367110.aspx
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| City: |
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Chapel Hill |
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State:
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NC |
| Zip Code: |
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27514 |
| Conditions: |
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HIV Infection |
| Purpose: |
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Integrase is an enzyme produced by HIV so that the virus can multiply in the human body.
GSK1349572 is a new drug in the integrase inhibitor class that prevents the enzyme from
working properly and therefore prevents the virus from multiplying.
GSK1349572 has shown to be effective against viruses in a short-term monotherapy study in
adults with no previous exposure to integrase inhibitors. The purpose of this study is to
determine whether GSK1349572 is effective in the treatment of HIV-infected patients who no
longer respond to treatment with the approved integrase inhibitor raltegravir and carry
viruses with resistance to this drug. The safety and efficacy of GSK1349572 50mg once daily
in combination with the background HIV drugs previously administered (unless discontinuation
of a particular drug is required) will be assessed over 10 days (functional monotherapy
phase), followed by the evaluation of the safety and efficacy of GSK1349572 given with a new
optimised background regimen from Day 11 through at least Week 24.
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| Study summary: |
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Study (ING112961) is a Phase IIb, multicentre, open-label, single arm pilot study to assess
the antiviral activity of GSK1349572 containing regimen in HIV-1 infected ART-experienced
adults with raltegravir (RAL) resistance. The study will include approximately 30
ART-experienced subjects with either current or past virologic failure to RAL. All subjects
must harbour isolates with RAL resistance mutations at Screening. Subjects should also have
documented genotypic and/or phenotypic resistance to at least one compound from each of
three or more of the approved classes of ART (including integrase inhibitors [INIs]).
Subjects with current RAL virologic failure will substitute RAL with GSK1349572 50mg once
daily and continue the remaining components of their failing regimen through Day 10.
Subjects with historical RAL virologic failure will add GSK1349572 50mg once daily to their
failing regimen through Day 10. On Day 11 all subjects will continue GSK1349572 and optimize
their background therapy. Antiviral activity, safety and tolerability of GSK1349572 will be
evaluated at Day 11 and over time through at least Week 24. |
| Criteria: |
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Inclusion Criteria:
- HIV-1 infected male or female adults at least 18 years of age with a plasma HIV-1 RNA
> 1,000 copies/mL at study entry. Women capable of becoming pregnant must use
appropriate contraception during the study (as defined by the protocol)
- ART-experienced (defined as on stable ART for at least the last 2 months) and is
either currently experiencing virologic failure to RAL or experienced virologic
failure to RAL > 8 weeks prior to Screening
- Must have documented RAL genotypic resistance on study entry genotype
- Must have documented genotypic or phenotypic resistance to at least one drug from
each of three or more of all approved classes of ART
- Willing and able to understand and provide signed and dated written informed consent
prior to screening
Exclusion Criteria:
- Any pre-existing mental, physical, or substance abuse disorder which, 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
- Currently take and/or anticipated need for EFV, NVP, FPV/RTV or TPV/RTV during the
study
- Treatment with any of the following medications within 15 days of starting study
drug, or anticipated to need, during the course of the study: Etravirine (unless
co-administered with LPV/RTV or DRV/RTV), rifampin, rifabutin, phenytoin,
phenobarbital, barbiturates, glucocorticoids, modafinil, oxcarbazepine, pioglitazone,
troglitazone, carbamazepine, St. Johns wort
- Previous participation in an experimental drug and/or vaccine trial(s) within 30 days
or 5 half-lives
- History of ongoing or clinically relevant pancreatitis or hepatitis within the
previous 6 months
- Expected to require treatment for HCV infection during the first 24 weeks of the
study
- Evidence of cirrhosis with or without hepatitis viral co-infection
- History of upper gastrointestinal bleed and/or active peptic ulcer disease
- Screening haemoglobin <10g/dL (100g/L)
- Subject suffers from a serious medical condition which could compromise the safety of
the subject.
- Any condition that could interfere with the absorption, distribution, metabolism or
excretion of the drug or render the subject unable to take oral medication
- Screening lipase 3 times the upper limit of normal (ULN)
- Any acute or Grade 4 laboratory abnormality at screening
- Screening alanine aminotransferase (ALT) >5xULN
- Screening ALT 3xULN and bilirubin 1.5xULN (with 35% direct bilirubin)
- Personal or family history of prolonged QT syndrome.
- Any clinically significant finding, as specified in the protocol, on screening or
baseline electrocardiograph (ECG)
- History of allergy to the study drugs or their components or drugs of their class
- Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days
prior to screening, or future need of treatment with these agents during the study
- Treatment with immunomodulators within 28 days prior to screening or subject has
received an HIV-1 vaccine within 90 days prior to screening |
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| Study is available at: |
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GSK Investigational Site
Chapel Hill, NC 27514
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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