Doravirine concentrations and antiviral activity in Cerebrospinal fluid in HIV-1 Infected individuals

Phase 1

• Conditions: HIV infected individuals; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2018-003915-24-ES
• Lead Sponsor: Fundacio Lluita contra la SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Asymptomatic, HIV-1 infected individuals = 18 years of age
2. Be on a stable ART continously or =3 consecutive months preceding the screening visit. Patients already receiving TAF/FTC+DoravirineC for at least three consecutive months will be eligible.
3. Plasma HIV-1 RNA at screening <40 copies/mL for at least 3 months at the Screening visit.
4. Signed and dated written informed consent prior to inclusion.
5. Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. Adequate renal function: Estimated glomerular filtration rate = 50 mL/min
8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
9. Current treatment with antiaggregant or anticoagulant therapy.
10. History of any neurologic disease/condition/treatment may alter the blood brain barrier permeability.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified