Phase 2
N=30
Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
HIV-1-infection
Bottom Line
View on ClinicalTrials.gov: NCT04097925 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Concentration of Doravirine in Seminal Plasma Fluid — 127 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doravirine (Drug); Descovy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Doravirine in Seminal Plasma Fluid |
127 | — |
| PRIMARY Concentration of Doravirine in Cervicovaginal Fluid |
505.8 | — |
| PRIMARY Number of Participants With HIV-1 RNA Seminal Plasma <40 Copies/mL |
15 | — |
| PRIMARY Quantification of Participants With HIV-1 RNA <40 Copies / mL in Cervicovaginal Fluid |
14 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04097925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.