NCT04097925

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Doravirine	Doravirine 100 mg tablet
DRUG	Descovy	Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet

Timeline

• Start date: 2020-02-18
• Primary completion: 2020-08-24
• Completion: 2020-08-24
• First posted: 2019-09-20
• Last updated: 2022-07-06
• Results posted: 2022-05-25

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study