Trial Outcomes & Findings for Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals (NCT NCT04079452)

Results Overview

Total Doravirine concentrations in cerebrospinal fluid in HIV-1 infected individual receiving ART with Doravirine+FTC/TAF

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

15 participants

Primary outcome timeframe

4 Weeks

Results posted on

2022-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Doravirie+TAF/FTC Arm (Single Arm) Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doravirine + Descovy® TAF/FTC n=15 Participants Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) coformulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 4 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Spain	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Population: Descriptive analysis was performed for all participants (15), defining median and IQR of Doravirine concentrations in CSF

Total Doravirine concentrations in cerebrospinal fluid in HIV-1 infected individual receiving ART with Doravirine+FTC/TAF

Outcome measures

Outcome measures
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 Participants Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
Total Doravirine Concentrations in Cerebrospinal Fluid	58.6 ng/ml Interval 23.2 to 127.3

PRIMARY outcome

Timeframe: 4 Weeks

Total Doravirine concentrations in blood plasma

Outcome measures

Outcome measures
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 Participants Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
Total Doravirine Concentrations in Blood Plasma	417.6 ng/ml Interval 169.5 to 942.2

PRIMARY outcome

Timeframe: 4 Weeks

total Doravirine CSF/plasma ratio

Outcome measures

Outcome measures
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 Participants Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
Total Doravirine Concentration CSF/Plasma Ratio	0.13 ratio Interval 0.09 to 0.19

PRIMARY outcome

Timeframe: 4 Weeks

Number of patients with HIV-1 RNA cerebrospinal fluid \<40 copies/ml

Outcome measures

Outcome measures
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 Participants Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
HIV-1 RNA in Cerebrospinal Fluid	13 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Number of patients with HIV-1 RNA in blood plasma \<40 copies/ml

Outcome measures

Outcome measures
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 Participants Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
HIV-1 RNA in Blood Plasma	14 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Population: Descriptive analysis was performed for all participants (15), defining median and IQR of Doravirine concentrations in CSF

Unbound Doravirine concentrations in cerebrospinal fluid in HIV-1 infected individual receiving ART with Doravirine+FTC/TAF

Outcome measures

Outcome measures
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 Participants Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
Unbound Doravirine Concentrations in CSF	44.6 ng/ml Interval 14.9 to 105.0

PRIMARY outcome

Timeframe: 4 Weeks

Unbound Doravirine concentrations in blood plasma

Outcome measures

Outcome measures
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 Participants Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
Doravirine Concentrations in Blood Plasma	53.5 CSF Unbound DORAVIRINE conc. ng/ml Interval 21.3 to 115.5

PRIMARY outcome

Timeframe: 4 Weeks

Unbound Doravirine CSF/plasma ratio

Outcome measures

Outcome measures
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 Participants Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
Unbound Doravirine Concentration CSF/Plasma Ratio	0.99 ratio Interval 0.83 to 1.17

Adverse Events

Doravirine+TAF/FTC Arm (Single Arm)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Doravirine+TAF/FTC Arm (Single Arm) n=15 participants at risk Doravirine (100 mg)+ Tenofovir Alafenamide (TAF) and emtricitabine (FTC) co-formulated (TAF/FTC 25/200 mg)
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 1 • 6 weeks
Musculoskeletal and connective tissue disorders Thoracic pain	6.7% 1/15 • Number of events 1 • 6 weeks

Additional Information

Clinical Project Manager

Hospital de Bellvitge

Phone: +34675335888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place