Clinical trial NCT04538040: Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-1-infection
Keywords: multi-drug resistant
Lead sponsor: Quest Clinical Research
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-09-03
Enrollment: 20
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Viral Suppression
timeFrame: 48 Weeks
Secondary outcomes:
measure: Tolerability of Study Drug
timeFrame: Week 48
measure: Change in Body Mass Index
timeFrame: Week 48
measure: Work Productivity and Activity
timeFrame: Week 48
measure: PK Assessment
timeFrame: Week 4 (+/- 14 days) with time points at predose (-0.5 hr), 0.5, 1, 2, 4, 6, 8, 12, and 24 hours
measure: Adverse Events Assessment
timeFrame: Day 28, Weeks 12, 24, 36, & 48
measure: Wellbeing Improvement
timeFrame: Week 48
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: SFOMG Private Practice
state: California
Study officials:
References: