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

NCT ID: NCT04097925

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-18
• Study Completion Date: 2020-08-24

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Doravirine

Intervention Type: DRUG

Doravirine 100 mg tablet

Descovy

Intervention Type: DRUG

Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet

Interventions

Doravirine

Doravirine 100 mg tablet

Intervention Type: DRUG

Descovy

Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet

Intervention Type: DRUG

Other Intervention Names

MK-1439; TAF/FTC

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Investigació Biomèdica de Bellvitge

OTHER

Sponsor Role: collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: collaborator

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

OTHER

Sponsor Role: lead

Responsible Party

Daniel Podzamczer

Chief of the HIV and STD Unit (Infectious Disease Service)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Podzamczer Palter, PhD Chief

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-003921-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DORAGEN

Identifier Type: -

Identifier Source: org_study_id