Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

• Sponsor: Quest Clinical Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT04538040
• Collaborator: Gilead Sciences (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection	Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Dec 19, 2019
• Actual Primary Completion Date: Nov 11, 2021
• Actual Study Completion Date: Nov 11, 2021

Arms and Interventions

Arm

Intervention/Treatment

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 Names: Biktarvy + Pifeltro Switch

Outcome Measures

Primary Outcome Measures

1. Viral Suppression [48 Weeks]

   Percentage of patients with viral HIV load (VL) <50 and <200 copies/mL at 48 weeks

Secondary Outcome Measures

1. Tolerability of study drug [Week 48]

   Tolerability of study drugs will be assessed by summarizing the number of AE/SAEs occurring during the study

2. Change in Body Mass Index [Week 48]

   Assess changes in BMI due to treatment switch

3. Work Productivity and Activity [Week 48]

   Improvement in work productivity and activity as measured by Work Productivity and Activity Impairment Questionnaire (WPAI)

4. PK Assessment [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®)

5. Adverse Events Assessment [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.

6. Wellbeing Improvement [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SFOMG Private Practice	San Francisco	California	United States	94114

Sponsors and Collaborators

• Quest Clinical Research
• Gilead Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Quest Clinical Research
• ClinicalTrials.gov Identifier: NCT04538040
• Other Study ID Numbers: BETD-001
• First Posted: Sep 3, 2020
• Last Update Posted: Jan 28, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Quest Clinical Research: multi-drug resistant
• Additional relevant MeSH terms: Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide

Study Results

No Results Posted as of Jan 28, 2022