HIV-1 infected subjects with CD4 nadir \> 200 cells/mm3, no history of virologic failure and plasma HIV RNA \<50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA \> 50 copies/mL before or at Week 24
DESIGN HIV-1 infected subjects with CD4 nadir \> 200 cells/mm3, no history of virologic failure and plasma HIV RNA \<50 copies/mL for at least 48 weeks while on any United States Department of Health and Human Services (DHHS) recommended or alternative three-drug antiretroviral regimen will be randomized to dolutegravir (DTG) plus lamivudine (Arm 1) or continuation of their current regimen (Arm 2) for 48 weeks. The primary endpoint is virologic failure defined as confirmed plasma HIV-1 RNA \> 50 copies/mL before or at Week 24 All subjects will undergo routine monitoring including plasma HIV-1 RNA, CD4/CD8 count, hematology, chemistry and fasting lipids. Resistance testing will be done in all patients who experience virologic failure. Single-copy HIV-1 assay will be done to quantify residual viremia. DURATION 48 weeks SAMPLE SIZE 90 subjects POPULATION HIV-1-infected men and women, 18 years and older, with CD4 nadir \> 200 cells/mm3, no baseline resistance, no history of virologic failure, and HIV RNA \<50 copies/mL for at least 48 weeks prior to study entry while on any DHHS recommended or alternative three-drug regimen REGIMEN Subjects will be randomized (1:1) to: Arm 1: dolutegravir 50 mg plus lamivudine 300 mg once daily OR Arm 2: Continue current DHHS recommended or alternative three-drug antiretroviral regimen
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
50 mg tablet by mouth once daily for 48 weeks
300 mg tablet by mouth once daily for 48 weeks
Continue current DHHS recommended or alternative three-drug antiretroviral regimen
University of California San Diego
San Diego, California, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Proportion of Participants With Treatment Failure
Proportion of participants with treatment failure (defined as virologic failure (HIV RNA \>50 copies/mL), loss to follow-up, or treatment discontinuation) between those who switch to DTG + lamivudine and those who continue their current ART regimen
Time frame: 24 weeks
Proportion of Participants With Virologic Success
Proportion of participants with virologic success (\<50 copies/mL) based on FDA snapshot definition
Time frame: 48 weeks
Change in CD4 Count From Baseline to Week 48
Change in CD4 count between arms will be presented in the attached statistical analysis table
Time frame: Baseline and 48 weeks
Change in Total Cholesterol From Baseline to Week 48
Change in Total Cholesterol between arms will be presented in the attached statistical analysis table
Time frame: Baseline and 48 weeks
Change in LDL Cholesterol From Baseline to Week 48
Change in Low-density lipoprotein (LDL) cholesterol between arms will be presented in the attached statistical analysis table
Time frame: Baseline and Week 48
Change in Creatinine Clearance From Baseline to Week 48
Change in Creatinine Clearance between arms will be presented in the attached statistical analysis table
Time frame: Baseline and Week 48
Drug Resistance Associated Mutations
Drug resistance mutations measured by HIV genotyping in patients with confirmed virologic failure
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Cornell University
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Time frame: 48 weeks