Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

HIV-1-infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538040
• Other study ID #: BETD-001
• Status: Completed
• Phase: Phase 4
• Start date: December 19, 2019
• Est. completion date: November 11, 2021

Study information

• Verified date: March 2024
• Source: Quest Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 11, 2021
• Est. primary completion date: November 11, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• HIV positive Males, age 45 or older

• Any genotypic or phenotypic resistance except k65R, 69 insertion, integrase resistance, or resistance to rilpivarine or doravirine.

• Receiving combination antiretroviral regimen of rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir > 12 months and with viral load <50 copies/ mL on at least one occasion within the six months prior to switch.

• Suppressed viral load as defined by one plasma HIV RNA level < 50 copies/mL within previous 6 months.

• Capable of providing informed consent

Exclusion Criteria:

• Any current or prior integrase inhibitor resistance

• Nucleoside reverse transcriptase (NRTI) mutation 69 insertion or k65R mutation

• Documented second generation non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance (rilpivirine or doravirine)

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

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.

Locations

Country	Name	City	State
United States	SFOMG Private Practice	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Quest Clinical Research	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Suppression	Percentage of patients with viral HIV load (VL) <50 and <200 copies/mL at 48 weeks	48 Weeks
Secondary	Tolerability of Study Drug	Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study	Week 48
Secondary	Change in Body Mass Index	Assess changes in BMI due to treatment switch	Week 48
Secondary	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.	Week 48
Secondary	PK Assessment	Subject plasma concentration-time data of bictegravir and doravirine will be analyzed using non-compartmental model (WinNonlin®)	Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours
Secondary	Adverse Events Assessment	Assess AE's of any grade and relationship to the drug combination occurring in at least 5% of participants or more.	Day 28, Weeks 12, 24, 36, & 48
Secondary	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.	Week 48