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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • MK-1439
Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Other Names:
  • TAF/FTC

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

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2020

Primary Completion (Actual)

August 24, 2020

Study Completion (Actual)

August 24, 2020

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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