Status:
COMPLETED
A Pilot Study Assessing the Integrase Inhibitor GSK1349572 in HIV-infected Persons With Virus Resistant to Raltegravir
Lead Sponsor:
ViiV Healthcare
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 th...
Detailed Description
Study (ING112961) is a Phase IIb, multicentre, open-label, single arm, two cohorts, pilot study to assess the antiviral activity of GSK1349572 containing regimen in HIV-1 infected ART-experienced adul...
Eligibility Criteria
Inclusion
- 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
- For Cohort II, Subjects MUST be able to receive at least one fully active drug as part of the Day 11 optimised background regimen
- Willing and able to understand and provide signed and dated written informed consent prior to screening
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00950859
Start Date
August 1 2009
End Date
January 1 2015
Last Update
December 4 2015
Active Locations (26)
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1
GSK Investigational Site
Phoenix, Arizona, United States, 85012
2
GSK Investigational Site
Long Beach, California, United States, 90813
3
GSK Investigational Site
San Francisco, California, United States, 94115
4
GSK Investigational Site
Denver, Colorado, United States, 80220