Health TrialsbyHealthPanel

Efficacy and Safety of Doravirine in the Rapid Initiation

ConditionHIV-1-infection
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Doravirine / lamivudine/ Tenofovir Disoproxil Oral Tablet

    Drug

    Pharmaceutical form: Oral tablets Unit dose concentration/dose level(s): 100/300/245 mg Administration instructions: Take one tablet once a day

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Doravirine /Lamivudine/ Tenofovir DisoproxilExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the antiviral activity of DOR/3TC/TDF at week 48 in HIV patients without prior antiretroviral treatment, in a rapid initiation setting.

Proportion of patients with a viral load \< 50 copies/mL at week 48, as determined by an intention-to-treat analysis (FDA snapshot analysis) of the exposed population (ITT-E)

Time frame
48 Weeks

Secondary outcomes

1

Evaluate the antiviral activity of DOR/3TC/TDF at < 200 copies/mL at week 48, using the intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E).

Proportion of patients with a viral load \< 200 copies/mL at week 48, using intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E).

Time frame
48 Weeks
2

Evaluate the antiviral activity of DOR/3TC/TDF at week 48 using an observed analysis (only including patients with available virological data).

Proportion of patients who achieved HIV-1 RNA levels \<50 copies/mL at week 48, in those with available data (observed analysis)

Time frame
48 Weeks
3

Evaluate the antiviral activity of DOR/3TC/TDF in the subgroup of participants with baseline ITINN mutations that do not confer resistance to doravirine, by calculating the proportion of patients with viral load <200 c/mL and <50 c/mL at week 48.

Proportion of patients with viral load \< 200 copies/mL and viral load \< 50 copies/mL at week 48 in the subgroup of participants with baseline ITINN mutations that do not confer resistance to doravirine, according to the list of mutations defined in the exclusion criteria.

Time frame
48 Weeks
4

Evaluate the antiviral activity of DOR/3TC/TDF at <200 copies/mL and <50 copies/mL at week 24.

Proportion of patients with viral load \< 200 copies/mL and viral load \< 50 copies/mL at week 24, using intention-to-treat analysis (FDA snapshot analysis) for the exposed population (ITT-E).

Time frame
24 Weeks

Other outcomes

Sponsors and contacts

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Fundación Huésped

Lead sponsor

MSD Pharmaceuticals LLC

Collaborator

Fundacion IDEAA

Collaborator

Source ClinicalTrials.gov
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