Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

NCT04538040 | Completed Phase 4 Results FDA Drug

• 1 other identifier: BETD-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-1-infection

Keywords

multi-drug resistant

Outcome Measures

Primary Outcomes (1)

• Viral Suppression

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

  48 Weeks

Secondary Outcomes (6)

• Tolerability of Study Drug

  Week 48

• Change in Body Mass Index

  Week 48

• Work Productivity and Activity

  Week 48

• 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

• Adverse Events Assessment

  Day 28, Weeks 12, 24, 36, & 48

Study Arms (1)

Biktarvy + Doravirine Switch

EXPERIMENTAL

bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets + doravirine 100mg tablets taken orally once per day

Drug: Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch

Interventions

Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch DRUG

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.

Also known as: Biktarvy + Pifeltro Switch

Biktarvy + Doravirine Switch

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Quest Clinical Research: lead
• Gilead Sciences: collaborator

Study Sites (1)

SFOMG Private Practice

San Francisco, California, 94114, United States

Location

MeSH Terms

Interventions

bictegravir; emtricitabine tenofovir alafenamide; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Results Point of Contact

• Title: Lisa Sterman, MD, MPH
• Organization: Gilead Sciences

Lisa.Sterman@Gilead.com

415-407-8434

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 3, 2020
• Study Start: December 19, 2019
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-03

Locations

US (1)