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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003921-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
| Hospital Universitari de Bellvitge | OTHER |
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This study aims to evaluate the ability of Doravirine to penetrate the genital tract and suppress viral replication and provide evidence for the use of Doravirine as part of treatment strategies as prevention.
Objectives:
Study Phase:
Phase II
Study Design:
Open label, single arm, single center, prospective study.
Study Disease:
HIV-1 infection
Study Endpoints:
Target Population:
Male and female adult HIV-1 infected patients receiving standard ART with tenofovir alafenamide/emtricitabine (TAF/FTC), tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine , plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor during at least 3 months, with plasma HIV-1 RNA suppression (<40 copies/mL) during at least 6 months.
Number of Subjects Planned:
15 male and 15 female individuals.
Study duration:
16 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doravirine + Descovy® TAF/FTC | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doravirine | Drug | Doravirine 100 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Doravirine in Seminal Plasma Fluid | Concentration of Doravirine in seminal plasma fluid in HIV-1 infected male individuals | 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC |
| Concentration of Doravirine in Cervicovaginal Fluid | Concentration of Doravirine in cervicovaginal fluid in HIV-1 infected female individuals | 8 weeks after switching to Doravirine plus TAF/FTC |
| Number of Participants 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 | 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC |
| Quantification of Participants With HIV-1 RNA <40 Copies / mL in Cervicovaginal Fluid | Number of participants with HIV-1 RNA cervicovaginal fluid<40 Copies / mL of HIV measured by real-Time Reverse Transcriptase Polymerase Chain Reaction Amplification | 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Podzamczer Palter, PhD Chief | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentration of Doravirine in Seminal Plasma Fluid | Concentration of Doravirine in seminal plasma fluid in HIV-1 infected male individuals | Descriptive analysis was performed for male participants (15), defining median and IQR of Doravirine concentrations in seminal plasma | Posted | Median | Inter-Quartile Range | ng/ml | 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Hospital de Bellvitge | +34675335888 | anavarroa@bellvitgehospital.cat |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 6, 2019 | Feb 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2019 | Apr 3, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 8, 2019 | Apr 3, 2022 | ICF_003.pdf |
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| ID | Term |
|---|---|
| C000592662 | doravirine |
| C000613801 | emtricitabine tenofovir alafenamide |
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Patients with Doravirine administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC) and administered orally once daily.
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| Descovy | Drug | Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Concentration of Doravirine in Cervicovaginal Fluid | Concentration of Doravirine in cervicovaginal fluid in HIV-1 infected female individuals | Descriptive analysis was performed for female participants (14), defining median and IQR of Doravirine concentrations in CVF | Posted | Median | Inter-Quartile Range | ng/ml | 8 weeks after switching to Doravirine plus TAF/FTC |
|
|
|
| Primary | Number of Participants 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 | Number of patients with HIV-1 RNA seminal plasma <40 copies/ml | Posted | Number | Number of participants | 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC |
|
|
|
| Primary | Quantification of Participants With HIV-1 RNA <40 Copies / mL in Cervicovaginal Fluid | Number of participants with HIV-1 RNA cervicovaginal fluid<40 Copies / mL of HIV measured by real-Time Reverse Transcriptase Polymerase Chain Reaction Amplification | Number of patients with HIV-1 RNA cervicovaginal fluid <40 copies/ml | Posted | Number | Number of participants | 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 18 |
| 30 |
| Headache | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Trichomonas vaginal infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| Poly-contusion due to fall | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Vomit | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Genital Herpes Virus infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| SARS-CoV-2 | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
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| Leg ulceration | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Right conjunctival effusion | Eye disorders | MedDRA (17.1) | Systematic Assessment |
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| Chlamydia trachomatis infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
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| Right eye hyposphagsma | Eye disorders | MedDRA (17.1) | Systematic Assessment |
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| Lithotripsy | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
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| tympanic perforation | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
|
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