The current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. The study will involve approximately 30 patients, which includes a PK arm of approximately 10 patients. The study will also include secondary outcomes of quality of life (QOL) and weight changes Hypothesis: Patients with prior NUC or NNRTI resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. The switch therapy will avoid food interactions, and will be well tolerated by subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
SFOMG Private Practice
San Francisco, California, United States
Viral Suppression
Percentage of patients with viral HIV load (VL) \<50 and \<200 copies/mL at 48 weeks
Time frame: 48 Weeks
Tolerability of Study Drug
Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study
Time frame: Week 48
Change in Body Mass Index
Assess changes in BMI due to treatment switch
Time frame: Week 48
Work Productivity and Activity
Improvement in work productivity and activity as measured by Work Productivity and Activity Impairment Questionnaire (WPAI). The range of the scale is 0-10, where 0 means it did not have an affect and 10 means it did have an affect.
Time frame: Week 48
PK Assessment
Subject plasma concentration-time data of bictegravir and doravirine will be analyzed using non-compartmental model (WinNonlin®)
Time frame: Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours
Adverse Events Assessment
Assess AE's of any grade and relationship to the drug combination occurring in at least 5% of participants or more.
Time frame: Day 28, Weeks 12, 24, 36, & 48
Wellbeing Improvement
Improvement in well-being and sleep inventory as measured by The Pittsburgh Sleep Quality Index (PSQI). Minimum score is 0 and maximum score is 21. A higher score indicates worse quality sleep.
Time frame: Week 48
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