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

NCT05140603 | Unknown

• 1 other identifier: FIS-DOR-2021-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with an HIV-1 viral load ≤ 50 and ≤ 200* copies/ml using snapshot algorithm.

  FDA snapshot algorithm (ITT-exposed).

  Up to 96 weeks.

Secondary Outcomes (5)

• Rate of changes in renal biomarkers.

  Up to 48 weeks.

• Rate of changes in hepatic parameters.

  Up to 48 weeks.

• Rate of changes in lipid parameters.

  Up to 48 weeks

• Tolerability rate of study patients.

  Up to 48 weeks.

• Death rates among trial patients.

  Up to 48 weeks.

Study Arms (1)

Cases

Patients who received a doravirine-based regimen.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who were switched to a doravirine-based regimen from the date of its availability in our center (September 2020) due to clinical considerations and have records available will be retrospectively included until the study approval date (expected July 2021). Minor resistances in a baseline genotype to NNRTI or prior failure to NNRTI such as nevirapine or efavirenz will be accepted if doravirine is combined with a fully active high genetic barrier drug.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nuria Espinosa Aguilera

  Virgen del Rocío University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuria Espinosa Aguilera

CONTACT

955 01 30 98; nuriai.espinosa.sspa@juntadeandalucia.es

Carlos García Pérez

CONTACT

955 04 31 27; administracion.eecc.hvm.sspa@juntadeandalucia.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 1, 2021
• Study Start: December 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: October 1, 2023
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

ES (1)