Doravirine concentrations and antiviral activity in genital fluids in HIV-1 infected individuals.

Doravirine concentrations and antiviral activity in genital fluids in HIV-1 infected individuals. - DORAGEN

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003921-27-ES

Enrollment

Registered

2019-04-12

Start date

2019-06-25

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infected individuals

Interventions

Product Name: DORAVIRINE Product Code: MK-1439 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DORAVIRINE CAS Number: 13382

Eligibility

Sex/Gender

All

Inclusion 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/lamivudina, plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor, continously for at least 3 consecutive months preceding the screening visit. 3. Plasma HIV-1 RNA =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Severe hepatic impairment (Child-Pugh Class C) 2. Ongoing malignancy 3. Active opportunistic infection 4. Primary resistance to any of the 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine Doravirine concentrations in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus TAF/FTC.;Secondary Objective: Evaluate HIV-1 viral load in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus TAF/FTC.;Timepoint(s) of evaluation of this end point: 16 weeks; Primary end point(s): - 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 TAF/FTC. -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 TAF/FTC.	—

Measure

Time frame

Main Objective: Determine Doravirine concentrations in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus TAF/FTC.;Secondary Objective: Evaluate HIV-1 viral load in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus TAF/FTC.;Timepoint(s) of evaluation of this end point: 16 weeks; Primary end point(s): - 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 TAF/FTC. -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 TAF/FTC.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints have not been established;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Spain

Contacts

Public ContactDaniel Podzamczer

Hospital Universitari de Bellvitge

dpodzamczer@bellvitgehospital.cat+34932607667

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026