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

NCT04097925 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: DORAGEN2018-003921-27
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection

Keywords

Doravirine

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Drug: Doravirine; Drug: Descovy

Interventions

Doravirine DRUG

Doravirine 100 mg tablet

Also known as: MK-1439

Doravirine + Descovy® TAF/FTC

Descovy DRUG

Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet

Also known as: TAF/FTC

Doravirine + Descovy® TAF/FTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator
• Hospital Universitari de Bellvitge: collaborator

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Interventions

doravirine; emtricitabine tenofovir alafenamide

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Hospital de Bellvitge

anavarroa@bellvitgehospital.cat

+34675335888

Study Officials

• Daniel Podzamczer Palter, PhD Chief

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the HIV and STD Unit (Infectious Disease Service)

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: February 18, 2020
• Primary Completion: August 24, 2020
• Study Completion: August 24, 2020
• Last Updated: July 6, 2022
• Results First Posted: May 25, 2022

Record last verified: 2022-06

Locations

ES (1)