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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ViiV Healthcare
With
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
