Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Concentration of Doravirine in Seminal Plasma Fluid
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Doravirine (Drug)
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
Intervention: Descovy (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniel Podzamczer
Chief of the HIV and STD Unit (Infectious Disease Service)
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia