NCT06155019Completed
Switch From Etravirine to Doravirine as a Part of Antiretroviral Combination
Switch From Etravirine to Doravirine as a Part of Antiretroviral Combination in Virologically Suppressed People Living With HIV (PLWH): the French Multicenter, Observational SWEED Study
Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 109 (actual)
- First submitted
- 24 Nov 2023
- Start date
- 8 Dec 2023
- Primary completion date
- 31 May 2024
- Lead sponsor
- Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
- Diseases
- HIV
- NCT number
- NCT06155019
What you commit to
- Study type: Observational
- Participants enrolled: 109
- From 8 Dec 2023 to the primary completion date, 31 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Subject under " sauvegarde de justice " (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pitié-Sapêtrière Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.