None listed
Conditions
Interventions
Dolutegravir treatment: 1 x 50 mg DTG tablet once daily plus 2 NRTIs selected by the investigator
Lopinavor/Ritonavir treatment: 4 x 200/50 mg LPV/RTV tablets once daily or 2 x 200/50 mg LPV/RTV ta
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected subjects ³18 years of age. 2. A female subject may be eligible to enter and participate in the study if she: a. is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ³45 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: • Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications. • Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide). • Approved hormonal contraception for subjects randomised to the DTG arm (see the SPM for a listing of examples of approved hormonal contraception). • Approved hormonal contraception and a barrier method for subjects randomised to the LPV/RTV arm (see the SPM for a listing of examples of approved hormonal contraception).
Exclusion criteria
Exclusion criteria: Exclusionary medical conditions 1. Women who are breastfeeding. 2. Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C disease (Section 11.2). Exceptions include cutaneous Kaposi’s sarcoma not requiring systemic therapy and historic or current CD4+ cell levels <200 cells/mm3. 3. Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification (see Appendix 1, Section 11.1). 4. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert´s syndrome or asymptomatic gallstones). 5. Anticipated need for hepatitis C virus (HCV) therapy during the Randomised Phase of the study. 6. History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. 7. Ongoing malignancy other than cutaneous Kaposi´s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localised malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject.
Countries
Argentina, Brazil, Chile, China, Colombia, Kenya, Mexico, Peru, Romania, Russian Federation, South Africa, Thailand, Ukraine
Contacts
Public ContactMilagros Mercedes Cardenas
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed