A Phase III study to demonstrate the antiviral activity and safetyof dolutegravir in HIV-1-infected adult subjects with treatmentfailure on an integrase inhibitor containing regimen.

Viiv Healthcare0 sites200 target enrollmentApril 4, 2011

Overview

No summary available.

Registry

who.int

Start Date

April 4, 2011

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Subject has documented HIV\-1 infection with a plasma HIV\-1 RNA \>\=500 copies/mL at Screening.
•2\.Subject is ART\-experienced and on stable ART for at least one month prior to Screening and through Day 1(with exceptions for ETV, EFV and NVP as detailed in Exclusion Criterion 11\).
•3\.Subject is INI\-experienced, but naïve to DTG, and either:
•currently experiencing virologic failure to RAL or ELV or
•experienced virologic failure while on therapy containing RAL or ELV (with documented genotypic and/or phenotypic INI resistance at time of failure) and is currently experiencing treatment failure on a subsequent regimen.
•4\.Subject harbours virus with :
•Evidence of genotypic resistance to RAL and/or ELV on Screening resistance testing.
•Evidence of phenotypic resistance to RAL on Screening resistance testing,
•No evidence of resistance at Screening but documented historical genotypic and/or phenotypic resistance to RAL and/or ELV at time of prior INI virological failure,
•Phenotypic resistance is defined as the IC50 above the biological cut\-off of the Phenosense assay for RAL (\>1\.5 FC versus wild type IC50\). For ELV phenotypic resistance is defined as \>2\.5 FC above WT IC50\. If assays other than the Monogram PhenoSense have been used to provide historical evidence of resistance, please discuss eligibility with the Study Virologist as specified in the Study Procedures Manual.

•Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
•A single repeat test (re\-test) per analyte is allowed during the screening period.
•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, 1993; See Appendix 2]. This definition excludes cutaneous Kaposi’s sarcoma (KS) not requiring systemic therapy or current CD4\+ cell levels \<200cells/mm3 (i.e. subjects with cutaneous KS or \<200 CD4\+cells/mm3 are eligible for inclusion).
•3\.Subjects with moderate to severe hepatic impairment as determined by Child\-Pugh classification (see Appendix 3\).
•4\.Anticipated need for HCV therapy during the first 24 weeks of the study.
•5\.Recent history (\<\=3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
•6\.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.