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Ambispective Cohort Study to Evaluate the Efficacy, Safety, and Tolerance of an Antiretroviral Regimen With Doravirine

Ambispective Cohort Study to Evaluate the Effectiveness, Safety and Tolerance of a Doravirine-based Antirretroviral Regimen as a Switching Strategy in Virologically Supressed HIV Infected Patients: Real-world Data

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05140603
Enrollment
150
Registered
2021-12-01
Start date
2021-12-01
Completion date
2023-10-01
Last updated
2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv

Brief summary

Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice.

Detailed description

Observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two NRTI or a dual therapy of doravirine plus dolutegravir (DTG) or bDRV in routinely clinical practice. All patients who were switched to a doravirine-based regimen from date of its availability in the center (September 2020) due to clinical considerations and have available records will be retrospectively included until date of study approval (expected on July 2021). Minor resistances in a basal genotype to NNRTI or previous failure to NNRTI as nevirapine or efavirenz will be accepted if doravirine it is combined with a high genetic barrier drug with complete activity.

Interventions

None listed

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Older than 18 years HIV-1 infected subjects. * Switched to a doravirine-based ART regimen under clinician criteria.

Exclusion criteria

* Doravirine major resistance mutations (accessory mutations are allowed). * Major mutations to any of the other drugs combined with doravirine. * Pregnancy, active tuberculosis or any condition that contraindicate the use of doravirine.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm.Up to 96 weeks.FDA snapshot algorithm (ITT-exposed).

Secondary

MeasureTime frameDescription
Rate of changes in renal biomarkers.Up to 48 weeks.Changes in renal biomarkers from baseline (mean absolute changes in glomerular filtrate estimation (eGFR and CKD-epi equation)/24 (interim analysis) and 48 weeks.
Rate of changes in hepatic parameters.Up to 48 weeks.Changes in hepatic parameters from baseline (median percentage of change in ASL, AST, GGT, AF and bilirubin).
Rate of changes in lipid parameters.Up to 48 weeksChanges in lipid parameters from baseline (median percentage of change in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CT-HDL ratio.
Tolerability rate of study patients.Up to 48 weeks.Number of interactions, adverse events and toxicities.
Death rates among trial patients.Up to 48 weeks.Number of patients who died during or after the trial.

Countries

Spain

Contacts

Primary ContactNuria Espinosa Aguilera
nuriai.espinosa.sspa@juntadeandalucia.es955 01 30 98
Backup ContactCarlos García Pérez
administracion.eecc.hvm.sspa@juntadeandalucia.es955 04 31 27

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026