Non-Interventional Observational Retrospective Study to Evaluate Doravirine Based-regimens in HIV Infected Aged Patients (DORAge).

NCT05202613 | Unknown FDA Drug

• 1 other identifier: 6496
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The HIV-infected population is aging due to the success of combination antiretroviral therapy, which prolongs survival, as well as the growing number of newly diagnosed cases in adults 50 years old and over. This real-life, observational and retrospective study aims to evaluate the virological efficacy, toxicity and tolerability of Doravirine-based regimens in aged HIV-1 positive patients (\> 50 years), focusing on metabolic patterns and inflammation markers.

Conditions

HIV

Keywords

HIV; Doravirine; Virological Failure; Metabolism; Inflammation

Outcome Measures

Primary Outcomes (1)

• Virological efficacy

  Assessing the virological efficacy (HIV RNA \< 50 copies/mL) of the Doravirine regimen at the end of the follow-up.

  48 weeks

Secondary Outcomes (6)

• Time to virological failure

  48 weeks

• Immunological changes

  Baseline to 48 weeks

• Safety profile

  Baseline to 48 weeks

• Lipid and metabolic profile

  Baseline to 48 weeks

• Infiammatory biomarkers

  48 weeks

Study Arms (2)

Dorage group

* HIV-1 infected patients * aged \> 50 years old * naive patients receiving doravirine-based regimens * experienced patients with persistent HIV RNA \< 50 copies/mLfor at least 6 months, who switched to doravirine-based regimens, because of toxicity, convenience or other reasons.

Drug: Doravirine

Control group

HIV negative subjects, matched for age and Charlson Index score (to evaluate comorbidity impact)

Interventions

Doravirine DRUG

Doravirine, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate

Dorage group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected patients

You may qualify if:

• HIV-1 infected patients
• aged \> 50 years old
• naive patients receiving doravirine-based regimens both as single drug and as in fixed combination with lamivudine and tenofovir disoproxil fumarate
• experienced patients with persistently undetectable plasma HIV viral load (HIV RNA \< 50 copies/mL) for at least 6 months, who switched from any antiretroviral drug to doravirine-based regimens, both as single drug and as fixed combination with lamivudine and tenofovir disoproxil fumarate, because of toxicity, convenience or other reasons.
• estimated creatinine clearance (CrCl) ≥50mL/min.

You may not qualify if:

• previous genotypic testing showing resistance mutations to doravirine
• acute hepatitis, decompensated liver disease, liver cirrhosis
• use of systemic immunosuppressive therapy

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Public Health and Infectious Diseases

Rome, Italy/RM, 00185, Italy

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

doravirine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gabriella d'Ettorre, Professor, MD

CONTACT

0649970801; gabriella.dettorre@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 21, 2022
• Study Start: January 4, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

IT (1)