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

• Status: Recruiting
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Collaborators: Hospital Universitari de Bellvitge; Institut d'Investigació Biomèdica de Bellvitge
• Treatments: Antiviral Agents; Emtricitabine tenofovir alafenamide

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.