- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097925
Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
Study Overview
Detailed Description
Objectives:
- To determine Doravirine concentrations in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving antiretroviral therapy (ATR) with Doravirine plus Descovy®.
- To evaluate HIV-1 viral load in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus Descovy®.
Study Phase:
Phase II
Study Design:
Open label, single arm, single center, prospective study.
Study Disease:
HIV-1 infection
Study Endpoints:
- Concentration of Doravirine in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals, respectively, 8 weeks after switching to Doravirine plus Descovy®.
- HIV-1 RNA in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals, respectively, 8 weeks after switching to Doravirine plus Descovy®.
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Barcelona
-
L'Hospitalet De Llobregat, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Asymptomatic, HIV-1 infected individuals ≥ 18 years of age.
- Be on a stable ART consisting of TAF/FTC, tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine, plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor, continuously for at least 3 consecutive months preceding the screening visit.
- Plasma HIV-1 RNA <40 copies/mL for at least 6 months at the Screening visit.
- Signed and dated written informed consent prior to inclusion.
- Female Subjects of Childbearing Potential must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.
Exclusion Criteria:
- Severe hepatic impairment (Child-Pugh Class C)
- Ongoing malignancy
- Active opportunistic infection
- Resistance to any of the antiretroviral (ARV) included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
- Any verified Grade 4 laboratory abnormality
- ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
- Severe renal impairment (Estimated creatinine filtration rate <50mL/min).
- Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 100 mg tablet
Other Names:
Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of Doravirine in Seminal Plasma Fluid
Time Frame: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
|
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
Time Frame: 8 weeks after switching to Doravirine plus TAF/FTC
|
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
Time Frame: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
|
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
Time Frame: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Daniel Podzamczer Palter, PhD Chief, Hospital Universitari de Bellvitge
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DORAGEN
- 2018-003921-27 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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