Status:
COMPLETED
Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborating Sponsors:
Institut d'Investigació Biomèdica de Bellvitge
Hospital Universitari de Bellvitge
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pr...
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04097925
Start Date
February 18 2020
End Date
August 24 2020
Last Update
July 6 2022
Active Locations (1)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907