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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
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A follicle stimulating hormone (FSH) level will be performed to confirm a post-menopausal status. For this study, FSH levels > 40 mlU/ml is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt, HRT should be discontinued for 2 weeks and then the subject rescreened, as HRT can suppress FSH. - Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication. - Body weight ≥ 50 kg for men and ≥ 45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg/m2 (inclusive). - Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: - The subject has a positive pre-study drug/alcohol screen. 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One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits. - Has a history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening. - Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication. - Pregnant females as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or prior to dosing. - Lactating females. - Unwillingness or inability to follow the procedures outlined in the protocol. - Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. 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A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. - The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) - History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. - Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. - If heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled. - History of regular alcohol consumption within 6 months of the study defined as: - An average weekly intake of >14 drinks/week for men or >7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits. - Has a history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening. - Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication. - Pregnant females as determined by positive serum or urine human chorionic gonadotrophin (hCG) test at screening or prior to dosing. - Lactating females. - Unwillingness or inability to follow the procedures outlined in the protocol. - Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy should be excluded. - History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease. - History/evidence of clinically significant pulmonary disease. - History of significant renal or hepatic diseases. - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. - A positive test for HIV antibody. - Serum creatinine values greater than the upper limit of normal. 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Pharmacovirological impact of an integrase inhibitor on HIV-1 cDNA species in vivo . Cold Spring Harbor Laboratory - 34th Annual Meeting on Retroviruses. 2009;","is_results_ref":"No","pubmed_id":""},{"citation":"Song I, Min S, Borland J, et al. The effect of ritonavir-boosted protease inhibitors (PIs) on the HIV integrase inhibitor, S/GSK1349572, in healthy Chemotherapy; September 12-15, 2009; San Francisco, CA. Abstract A1-1304.","is_results_ref":"No","pubmed_id":""}],"is_section_801":false}},"pageContext":{"studyId":"111405"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}