A Phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects.

ViiV Healthcare UK Ltd0 sites822 target enrollmentStarted: September 7, 2010Last updated: December 13, 2021

Overview

No summary available.

•Eligible subjects must
•be able to understand and comply with protocol requirements, instructions, and restrictions.
•be likely to complete the study as planned.
•be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease).
•Laboratory results from the central laboratory services provided by this trial will be used to assess eligibility. If results from the central laboratory (e.g., genotype results) will delay screening beyond the defined 28\-day period, use of local laboratory results may be used only after consultation and agreement with GSK.
•Subjects eligible for enrolment in this study must meet all of the following criteria:
•1\.HIV\-1 infected adults \> 18 years of age.
•2\.A female may be eligible to enter and participate in the study if she:
•a)is of non\-child\-bearing potential defined as either post\-menopausal (12 months of spontaneous amenorrhea and \>45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
•b)is of child\-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:

•Subjects meeting any of the following criteria must not be enrolled in the study:
•Exclusionary medical conditions
•1\.Women who are breastfeeding;
•2\.Any evidence of an active Center for Disease and Prevention Control (CDC) Category C disease \[CDC, 1992], except cutaneous Kaposi’s sarcoma not requiring systemic therapy or historic or current CD4\+ cell levels \<200cells/mm3;
•3\.Subjects with moderate to severe hepatic impairment as determined by Child\-Pugh classification (see Appendix 1\);
•4\.Anticipated need for HCV therapy during the study;
•5\.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class;
•6\.History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non\-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and GSK medical monitor for inclusion of the subject;
•Exclusionary Treatments prior to Screening or Day 1
•7\.Treatment with an HIV\-1 immunotherapeutic vaccine within 90 days of Screening;

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