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

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ClinicalTrials.gov Identifier: NCT04097925
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Institut d'Investigació Biomèdica de Bellvitge
Hospital Universitari de Bellvitge
Information provided by (Responsible Party):
Daniel Podzamczer, Fundacio Lluita Contra la SIDA

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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Doravirine Drug: Descovy Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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
Drug: Doravirine
Doravirine 100 mg tablet
Other Name: MK-1439

Drug: Descovy
Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Other Name: TAF/FTC




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097925


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

Locations
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Spain
Hospital Universitari de Bellvitge
L'Hospitalet De Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Fundacio Lluita Contra la SIDA
Institut d'Investigació Biomèdica de Bellvitge
Hospital Universitari de Bellvitge
Investigators
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Principal Investigator: Daniel Podzamczer Palter, PhD Chief Hospital Universitari de Bellvitge

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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 ( EudraCT Number )
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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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
Additional relevant MeSH terms:
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Antiviral Agents
Anti-Infective Agents