Trial Outcomes & Findings for Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals (NCT NCT04097925)

NCT ID: NCT04097925

Last Updated: 2022-07-06

Results Overview

Concentration of Doravirine in seminal plasma fluid in HIV-1 infected male individuals

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
• Results posted on: 2022-07-06

Participant Flow

Participant milestones

Measure	Doravirine + Descovy® TAF/FTC Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Doravirine + Descovy® TAF/FTC Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals

Baseline characteristics by cohort

Measure	Doravirine + Descovy® TAF/FTC n=30 Participants Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 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	30 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	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC

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

Concentration of Doravirine in seminal plasma fluid in HIV-1 infected male individuals

Outcome measures

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) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Concentration of Doravirine in Seminal Plasma Fluid	127 ng/ml Interval 31.2 to 272.0

PRIMARY outcome

Timeframe: 8 weeks after switching to Doravirine plus TAF/FTC

Population: Descriptive analysis was performed for female participants (14), defining median and IQR of Doravirine concentrations in CVF

Concentration of Doravirine in cervicovaginal fluid in HIV-1 infected female individuals

Outcome measures

Measure	Doravirine + Descovy® TAF/FTC n=14 Participants Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Concentration of Doravirine in Cervicovaginal Fluid	505.8 ng/ml Interval 199.8 to 960.8

PRIMARY outcome

Timeframe: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC

Population: Number of patients with HIV-1 RNA seminal plasma \<40 copies/ml

Number of participants with HIV-1 RNA seminal plasma <40 Copies / mL of HIV measured by real-Time Reverse Transcriptase Polymerase Chain Reaction Amplification

Outcome measures

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) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Number of Participants With HIV-1 RNA Seminal Plasma <40 Copies/mL	15 Number of participants

PRIMARY outcome

Timeframe: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC

Population: Number of patients with HIV-1 RNA cervicovaginal fluid \<40 copies/ml

Number of participants with HIV-1 RNA cervicovaginal fluid<40 Copies / mL of HIV measured by real-Time Reverse Transcriptase Polymerase Chain Reaction Amplification

Outcome measures

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) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Quantification of Participants With HIV-1 RNA <40 Copies / mL in Cervicovaginal Fluid	14 Number of participants

Adverse Events

Doravirine + Descovy® TAF/FTC

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Doravirine + Descovy® TAF/FTC n=30 participants at risk Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Reproductive system and breast disorders Metrorrhagia	3.3% 1/30 • Number of events 1 • 16 weeks
General disorders Headache	3.3% 1/30 • Number of events 1 • 16 weeks
Infections and infestations Trichomonas vaginal infection	3.3% 1/30 • Number of events 1 • 16 weeks
Musculoskeletal and connective tissue disorders Poly-contusion due to fall	3.3% 1/30 • Number of events 1 • 16 weeks
Gastrointestinal disorders Vomit	3.3% 1/30 • Number of events 1 • 16 weeks
Respiratory, thoracic and mediastinal disorders Cough	3.3% 1/30 • Number of events 1 • 16 weeks
Gastrointestinal disorders Diarrhea	6.7% 2/30 • Number of events 2 • 16 weeks
Infections and infestations Genital Herpes Virus infection	3.3% 1/30 • Number of events 1 • 16 weeks
Infections and infestations SARS-CoV-2	3.3% 1/30 • Number of events 1 • 16 weeks
Renal and urinary disorders Renal colic	6.7% 2/30 • Number of events 2 • 16 weeks
Skin and subcutaneous tissue disorders Leg ulceration	3.3% 1/30 • Number of events 1 • 16 weeks
Eye disorders Right conjunctival effusion	3.3% 1/30 • Number of events 1 • 16 weeks
Infections and infestations Chlamydia trachomatis infection	3.3% 1/30 • Number of events 1 • 16 weeks
Eye disorders Right eye hyposphagsma	3.3% 1/30 • Number of events 1 • 16 weeks
Hepatobiliary disorders Lithotripsy	3.3% 1/30 • Number of events 1 • 16 weeks
Ear and labyrinth disorders tympanic perforation	3.3% 1/30 • Number of events 1 • 16 weeks

Additional Information

Clinical Project Manager

Hospital de Bellvitge

Phone: +34675335888

Email: anavarroa@bellvitgehospital.cat

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place