Switch From Etravirine to Doravirine as a Part of Antiretroviral Combination

NCT06155019 | Completed

• 1 other identifier: CREPATS 16
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the SWEED study is to determine whether doravirine containing ART is able to maintain viral suppression at W48 in HIV-1 infected people living with HIV (PLWH) receiving etravirine containing ART:

• An ARV strategy containing doravirine as a replacement for etravirine can maintain virological suppression in participants with controlled viral replication under ARV treatment containing etravirine, with a virological success rate \>90%
• This strategy can maintain virological suppression even in the event of NNRTI resistance mutations acquired in the past
• This strategy is well tolerated
• The emergence of resistance to NNRTIs is uncommon in the event of virological failure under the ARV regimen containing doravirine

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Measure the virological efficacy at week 48 a doravirine-containing ART to assess the effectiveness of the switch to maintain the virological success to W48

  Measure of plasma viral load assessed by RNA quantification using COBAS 6800 system (Roche)

  12 months

Study Arms (1)

Non comparative

switch from etravirine to doravirine, with no change in associated antiretroviral drugs, will be assessed retrospectively

Eligibility Criteria

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

Study Population

This observational, non-interventional, multicenter study will assess the efficacy of switching etravirine to doravirine in virally suppressed PLWH on stable etravirine containing ART, with at least 48 weeks of follow-up

You may qualify if:

• Patients over 18 years
• With HIV-1 infection
• On a regimen containing etravirine QD or BID combined with at least one other antiretroviral from any class except NNRTI
• Who had switched for a regimen containing doravirine combined with the same number of other antiretrovirals
• With plasma HIV-RNA \<50 copies/mL for at least 12 months (one blip \<200 copies/mL permitted) at time of switch to doravirine
• With at least 2 available pVL after the switch, and at least 48 weeks between the switch and the last available pVL\*
• Who gave their non-opposition for the study
• For patients who stopped doravirine-based treatment or were lost to follow-up before 48 weeks, only the theoretical duration of follow-up will be taken into account (time between the switch and the date of analysis)

You may not qualify if:

• \- Subject under " sauvegarde de justice " (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship

Sponsors & Collaborators

• Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida: lead

Study Sites (1)

Pitié-Sapêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Romain PALICH, DR

  Pitie-Salpetriere Hospital, Infectious Diseases department

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: December 8, 2023
• Primary Completion: May 31, 2024
• Study Completion: September 15, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

FR (1)