Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2020 by Daniel Podzamczer, Fundacio Lluita Contra la SIDA

Sponsor
Fundacio Lluita Contra la SIDA

Collaborator
Institut d'Investigació Biomèdica de Bellvitge
Hospital Universitari de Bellvitge

Information provided by (Responsible Party)
Daniel Podzamczer, Fundacio Lluita Contra la SIDA

ClinicalTrials.gov Identifier
NCT04097925

First received: September 18, 2019
Last updated: May 5, 2020
Last Verified: May 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV-1-infection

Drug : Doravirine
Drug : Descovy
Phase 2

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals

Further study details as provided by Daniel Podzamczer, Fundacio Lluita Contra la SIDA:

Primary Outcome Measures

  • Concentration of Doravirine in seminal plasma fluid [ Time Frame: 8 weeks after switching to Doravirine plus TAF/FTC ]
    Concentration of Doravirine in seminal plasma fluid in HIV-1 infected male individuals
  • 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
  • Quantification number of copies / mL of HIV in seminal plasma [ Time Frame: 8 weeks after switching to Doravirine plus TAF/FTC ]
    Quantification of copies / mL of HIV in seminal plasma in HIV-1 infected male individuals
  • Quantification number of copies / mL of HIV in cervicovaginal fluid [ Time Frame: 8 weeks after switching to Doravirine plus TAF/FTC ]
    Quantification of copies / mL of HIV in cervicovaginal fluid in HIV-1 infected female individuals

Estimated Enrollment: 30
Study Start Date: February 18, 2020
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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
Drug: Doravirine

Doravirine 100 mg tablet

Other Name: MK-1439
Drug: Descovy

Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet

Other Name: TAF/FTC

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

    Eligibility

    Eligibility

    Ages Eligible for Study: 18 Years and older  
    Sexes Eligible for Study: All  
    Accepts Healthy Volunteers: No  

    Criteria

    Inclusion Criteria:

      1. Asymptomatic, HIV-1 infected individuals ≥ 18 years of age.
      2. 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.
      3. Plasma HIV-1 RNA <40 copies/mL for at least 6 months at the Screening visit.
      4. Signed and dated written informed consent prior to inclusion.
      5. 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:
      1. Severe hepatic impairment (Child-Pugh Class C)
      2. Ongoing malignancy
      3. Active opportunistic infection
      4. 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.
      5. Any verified Grade 4 laboratory abnormality
      6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
      7. Severe renal impairment (Estimated creatinine filtration rate <50mL/min).
      8. Females who are pregnant (as confirmed by positive serum pregnancy test) or
      breastfeeding.

    contacts and locations

    Contacts and Locations

    Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT04097925

    Contacts

    Contact:   Arkaitz Imaz, PhD +34932607667 ext 2883 aimaz@bellvitgehospital.cat
    Contact:   Juan Manuel Tiraboschi, PhD +34932607667 ext 2885 jmtiraboschi@bellvitgehospital.cat

    Locations

    Spain
    Hospital Universitari de Bellvitge Recruiting
    L'Hospitalet De Llobregat, Barcelona, Spain, 08907
    Contact: Sandra Morenilla    +34933359011 ext 2913    smorenilla@bellvitgehospital.cat
    Contact: Laura Acerete    +34933359011 ext 2876    lacerete@bellvitgehospital.cat
    Principal Investigator: Daniel Podzamczer, PhD
    Sub-Investigator: Arkaitz Imaz, PhD
    Sub-Investigator: Juan Manuel Tiraboschi, PhD

    Sponsors and Collaborators

    Fundacio Lluita Contra la SIDA
    Institut d'Investigació Biomèdica de Bellvitge
    Hospital Universitari de Bellvitge

    Investigators

    Principal Investigator: Daniel Podzamczer Palter, PhD Chief Hospital Universitari de Bellvitge
    More Information

    More Information


    Responsible Party: Daniel Podzamczer, Chief of the HIV and STD Unit (Infectious Disease Service), Fundacio Lluita Contra la SIDA  
    ClinicalTrials.gov Identifier: NCT04097925   History of Changes  
    Other Study ID Numbers: DORAGEN  
      2018-003921-27  
    Study First Received: September 18, 2019  
    Last Updated: May 5, 2020  

    Studies a U.S. FDA-regulated Drug Product: Yes  
    Studies a U.S. FDA-regulated Device Product: No  

    Keywords provided by Daniel Podzamczer, Fundacio Lluita Contra la SIDA:

    Doravirine

    ClinicalTrials.gov processed this data on May 24, 2020
    This information is provided by ClinicalTrials.gov.