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

Phase 1

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

• Registration Number: EUCTR2018-003921-27-ES
• Lead Sponsor: luita contra la SIDA Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

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 <40 copies/mL for at least 6 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
(*) Highly effective methods of contraception as defined by the Clinical Trial Facilitation Group (CTFG) (Recommendations related to contraception and pregnancy testing in clinical trials”, version 15/09/2014): 1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); 3. Intrauterine device (IUD); 4. Intrauterine hormone-releasing system (IUS); 5. Bilateral tubal occlusion; 6. Vasectomised partner; 7. Sexual abstinence.
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 30
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. Severe renal impairment (Estimated creatinine filtration rate <50mL/min).
8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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;<br> 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.<br> -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.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints have not been established;Timepoint(s) of evaluation of this end point: not applicable