Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine
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|ClinicalTrials.gov Identifier: NCT04538040|
Recruitment Status : Active, not recruiting
First Posted : September 3, 2020
Last Update Posted : September 11, 2020
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
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV-1-infection||Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study Evaluating the 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 HIV+ Subjects > 45 Years With Multi-drug Resistant Virus and Virologic Suppression (Documented With at Least One Viral Load Result < 50 Copies Per mL) During the Last 6 Months on Current Therapy|
|Actual Study Start Date :||December 19, 2019|
|Estimated Primary Completion Date :||April 21, 2021|
|Estimated Study Completion Date :||April 21, 2021|
Experimental: Biktarvy + Doravirine Switch
bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day
Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch
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.
Other Name: Biktarvy + Pifeltro Switch
- Viral Suppression [ Time Frame: 48 Weeks ]Percentage of patients with viral HIV load (VL) <50 and <200 copies/mL at 48 weeks
- Tolerability of study drug [ Time Frame: Week 48 ]Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study
- Change in Body Mass Index [ Time Frame: Week 48 ]Assess changes in BMI due to treatment switch
- Work Productivity and Activity [ Time Frame: Week 48 ]Improvement in work productivity and activity as measured by Work Productivity and Activity Impairment Questionnaire (WPAI)
- PK Assessment [ 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 ]Subject plasma concentration-time data of bictegravir and doravirine will be analyzed using non-compartmental model (WinNonlin®)
- Adverse Events Assessment [ Time Frame: Day 28, Weeks 12, 24, 36, & 48 ]Assess AE's of any grade and relationship to the drug combination occurring in at least 5% of participants or more.
- Wellbeing Improvement [ Time Frame: Week 48 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04538040
|United States, California|
|SFOMG Private Practice|
|San Francisco, California, United States, 94114|