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UBMD Physicians' Group

Clinical Trials

A Phase IIb, Dose Ranging Study of Oral GSK1265744 in Combination With Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus -1 (HIV-1) Virologic Suppression Followed by an Evaluation of Maintenance of Virologic Suppression When Oral GSK1265744 is Combined With Oral Rilpivirine in HIV-1 Infected, Antiretroviral Therapy Naive Adult Subjects

Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine

Proportion of subjects with HIV-1 RNA <50 copies/mL at Week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Proportion of subjects with HIV-1 RNA <50 copies/mL at Week 48 will be based on Intent-to-Treat Exposed (ITT-E) Population (all randomized subjects who received at least one dose of study drug) using the missing, switch, or discontinuation equals failure (MSDF) algorithm.

Eligibility

Inclusion Criteria:
•HIV-1 infected male or female subjects >= 18 years of age
•Screening plasma HIV-1 RNA >=1000 c/mL
•CD4+ cell count >=200 cells/millimeter (mm)^3
•ART-naive defined as having =<10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
•Female subjects of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy during the study

Exclusion Criteria:
•Any evidence at screening of an active Centers for Disease and Prevention Control (CDC) Category C disease
•Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
•History of ongoing or clinically relevant hepatitis within the previous 6 months, and subjects with moderate to severe hepatic impairment will be excluded
•Women who are breastfeeding
•Subject, who in the investigator's judgment, poses a significant suicide risk
•Any clinically significant finding on screening or baseline electrocardiograph (ECG)
•The presence of any specific laboratory abnormalities at Screening
•History of cardiac disease
•Clinically relevant pancreatitis
•Subjects who are unlikely to complete the dosing schedule due to a pre-existing physical or mental condition
•Any condition which impairs the absorption, distribution, metabolism or excretion of the investigational product
•Any evidence of primary resistance based upon the presence of a major resistance associated mutation in the Screening HIV genotype, or any historical genotype
•Treatment with any protocol-specified excluded medication

Investigator

Alyssa Shon, MD

Contact Information

Name: Alyssa Shon, MD
Phone: 898-4119
Email: alyssash@buffalo.edu