A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects
Completed · Phase 2
Conditions studied: Infection, Human Immunodeficiency Virus
In brief
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.
Key facts
- Study ID
- NCT00951015
- Run by
- ViiV Healthcare
- People needed
- 208
- Starts
- 2009-07-30
- Expected to finish
- 2016-12-22
- Last updated by the study team
- 2018-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 200cells/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.
You may not qualify if…
- 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.
Where it is running
- GSK Investigational Site — Phoenix, Arizona, United States
- GSK Investigational Site — Bakersfield, California, United States
- GSK Investigational Site — Long Beach, California, United States
- GSK Investigational Site — San Francisco, California, United States
- GSK Investigational Site — Denver, Colorado, United States
- GSK Investigational Site — Washington D.C., District of Columbia, United States
- GSK Investigational Site — Fort Lauderdale, Florida, United States
- GSK Investigational Site — Fort Lauderdale, Florida, United States
- GSK Investigational Site — Fort Lauderdale, Florida, United States
- GSK Investigational Site — Orlando, Florida, United States
- GSK Investigational Site — Santa Fe, New Mexico, United States
- GSK Investigational Site — Charlotte, North Carolina, United States
- GSK Investigational Site — Dallas, Texas, United States
- GSK Investigational Site — Lyon, France
- GSK Investigational Site — Montpellier, France
- GSK Investigational Site — Nantes, France
- GSK Investigational Site — Paris, France
- GSK Investigational Site — Paris, France
- GSK Investigational Site — Paris, France
- GSK Investigational Site — Frankfurt am Main, Hesse, Germany
- GSK Investigational Site — Hanover, Lower Saxony, Germany
- GSK Investigational Site — Hamburg, Germany
- GSK Investigational Site — Hamburg, Germany
- GSK Investigational Site — Bergamo, Lombardy, Italy
- GSK Investigational Site — Brescia, Lombardy, Italy
Full record on ClinicalTrials.gov
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