HIV-1-infectionPhase 2NCT04097925

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

A Phase 2 study testing Doravirine and Descovy in people with HIV-1-infection, run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV-1-infection
What is being tested?: Doravirine and Descovy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSpain
Study dates: 18 Feb 2020to 24 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Signed and dated written informed consent prior to inclusion.
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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

Read the 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
Being tested: Doravirine, Descovy
Keywords: Doravirine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DoravirineDrug
Also called MK-1439
Doravirine 100 mg tablet
DescovyDrug
Also called TAF/FTC
Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet

Study groups in NCT04097925
Study group	Role	What they receive
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 Receives: Drug: Doravirine; Drug: Descovy

What is being measured

The primary outcome is the main question the study is designed to answer.

Concentration of Doravirine in Seminal Plasma Fluid
Concentration of Doravirine in seminal plasma fluid in HIV-1 infected male individuals
Measured: 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
Measured: 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
Measured: 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
Measured: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 202024 Aug 2020

First posted20 Sep 2019
Study start18 Feb 2020
Primary completion24 Aug 2020
Study completion24 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04097925
Sponsor's protocol ID: DORAGEN
Other IDs: 2018-003921-27, 2018
Status last verified: Jun 2022
First submitted: 18 Sep 2019
Last updated: 6 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
ClinicalTrials.gov ID: NCT04097925
Acronym / sponsor ID: DORAGEN
Conditions: HIV-1-infection
Keywords: Doravirine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaUniversity, hospital or other
Collaborators: Institut d'Investigació Biomèdica de Bellvitge, Hospital Universitari de Bellvitge
Study start: 18 Feb 2020 (actual)
Primary completion: 24 Aug 2020 (actual)
Study completion: 24 Aug 2020 (actual)
First posted: 20 Sep 2019 (actual)
Results: Posted 25 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Number of Subjects Planned:

15 male and 15 female individuals.

Study duration:

16 weeks

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Doravirine + Descovy® TAF/FTC	Experimental	Drug: Doravirine, Drug: DescovyDoravirine (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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.
Signed and dated written informed consent prior to inclusion.
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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DoravirineAlso: MK-1439Doravirine 100 mg tablet	Drug	Doravirine + Descovy® TAF/FTC
DescovyAlso: TAF/FTCTenofovir alafenamide 25 mg / emtricitabine 200 mg tablet	Drug	Doravirine + Descovy® TAF/FTC

Primary outcome

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
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
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
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

Results and safety

Results posted to the registry on 25 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Doravirine + Descovy® TAF/FTC	30	29

Primary outcome: Concentration of Doravirine in Seminal Plasma Fluid

Time frame: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC. Median (Inter-Quartile Range). Unit: ng/ml

Measure	Doravirine + Descovy® TAF/FTC n = 15
Value	127 (31.2 to 272)

Population analysed: Descriptive analysis was performed for male participants (15), defining median and IQR of Doravirine concentrations in seminal plasma

Primary outcome: Concentration of Doravirine in Cervicovaginal Fluid

Time frame: 8 weeks after switching to Doravirine plus TAF/FTC. Median (Inter-Quartile Range). Unit: ng/ml

Measure	Doravirine + Descovy® TAF/FTC n = 14
Value	505.8 (199.8 to 960.8)

Population analysed: Descriptive analysis was performed for female participants (14), defining median and IQR of Doravirine concentrations in CVF

Primary outcome: 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. Unit: Number of participants

Measure	Doravirine + Descovy® TAF/FTC n = 15
Value	15

Population analysed: Number of patients with HIV-1 RNA seminal plasma \<40 copies/ml

Primary outcome: 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. Unit: Number of participants

Measure	Doravirine + Descovy® TAF/FTC n = 15
Value	14

Population analysed: Number of patients with HIV-1 RNA cervicovaginal fluid \<40 copies/ml

Adverse events

Time frame: 16 weeks. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Doravirine + Descovy® TAF/FTC	0 of 30 (0%)	18 of 30 (60%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Podzamczer Palter, PhD Chief principal investigator

Hospital Universitari de Bellvitge

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Doravirine in Seminal Plasma Fluid (time frame: 8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04097925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.