Efficacy and Safety of Doravirine in the Rapid Initiation
ConditionHIV-1-infection
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorFundación Huésped
About this trial
Protocol title: "Efficacy and safety of doravirine in the rapid initiation of highly active antiretroviral therapy (HAART) in HIV-1positive patients without prior treatment."
Eligibility criteria
Qualifiers
Subject has to voluntarily signed and dated an informed consent form, approved by an institutional ethics committee.
≥18 years of age.
Not previously exposed to ARV (naïve). Subject may have received oral PrEP and PEP within the last 6 months and injectable PrEP and PEP within the last year.
Have a received an HIV diagnosis within 30 days prior to selection. Defined as: Having confirmed HIV-1 infection. HIV-1 positive result is considered if the HIV1 RNA in plasma is ≥ 1000 copies/mL or two HIV antibody tests (using two different tests) are positive.
Disqualifiers
History of hypersensitivity to doravirine, tenofovir, or lamivudine.
Severe hepatic impairment (Child-Pugh C).
Active HCV infection requiring specific treatment during study participation at the time of eligibility assessment. If HCV is diagnosed during the study and the participant requires treatment, the decision on whether to continue in the study will be at the investigator's discretion.
Women without reproductive capacity, defined as premenopausal women with tubal ligation or hysterectomy, or documented bilateral oophorectomy; or as postmenopausal women with 12 months of spontaneous amenorrhea, and women ≥ 45 years of age without hormone replacement therapy.
Trial design
Treatments tested in this trial
- Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov