Phase 2b study to select a once daily oral dose of GSK2248761 administered with tenofovir/emtricitabine or abacavir/lamivudine in HIV-1 infected antiretroviral therapy naive adult subjects

ViiV Healthcare UK Ltd0 sites150 target enrollmentSeptember 17, 2010

ConditionsHIV-1 infected antiretroviral therapy naive adult subjects MedDRA version: 12.1Level: LLTClassification code 10008922Term: Chronic infection with HIV

DrugsSUSTIVA

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV-1 infected antiretroviral therapy naive adult subjects
Sponsor: ViiV Healthcare UK Ltd
Enrollment: 150
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 17, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ViiV Healthcare UK Ltd

Eligibility Criteria

Inclusion Criteria

•1\) HIV\-1 infected adults \=18 years of age. A female is eligible to enter and participate in the study if she falls into one of the following categories:
•a. Non\-childbearing potential; or, b. Child\-bearing potential, with a negative pregnancy test at screen and Day 1 and agrees to one of the methods of contraception listed below. Premenarchal females who develop child\-bearing potential while on study will also be expected to follow one of the methods of contraception listed below:
•\-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. Should a subject of child\-bearing potential decide to
•become sexually active during the course of the study, she must be counseled
•and be willing to use one of the other contraception methods listed below:
•\-Double barrier method (male condom/spermicide, male condom/diaphragm,
•diaphragm/spermicide).
•\-Any intrauterine device (IUD) with published data showing that the expected

Exclusion Criteria

•1\)Any pre\-existing physical or mental condition (including substance abuse disorder) which, may interfere with the subject’s ability to comply with the study requirements or which may compromise the safety of the subject
•2\)Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to take oral medication
•3\)Women who are currently breastfeeding
•4\)Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease, except cutaneous Kaposi’s sarcoma not requiring systemic therapy
•5\)History of ongoing or clinically relevant hepatitis within the previous 6 months, including chronic hepatitis B virus (HBV) infection (HBsAg positive). Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded
•6\)History of liver cirrhosis with or without hepatitis viral co\-infection;
•7\)Ongoing or clinically relevant pancreatitis
•8\)History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia;
•9\)Personal or known family history of prolonged QT syndrome
•10\)History or presence of allergy or intolerance to the study drugs or their components, or a history of drug or other allergy that, in the opinion of the Principal Investigator, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin\-induced thrombocytopenia should not be enrolled