HIV Infections
Conditions
Brief summary
This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed. The study will be performed only on two sites
Detailed description
The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.
Interventions
DRUGDoravirine
switches from etravirine to doravirine, in experienced HIV patients
Sponsors
Merck Frosst Canada Ltd.
Clinique du Quartier Latin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A pilot, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
\- Adult (18 Y.O. or more) women and men infected with HIV. * Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months. * Virologically controlled (HIV-1 RNA \< 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed. * Presence of at least one major NNRTI mutation. * No limitation on the number of previous regimens. * HCV and HBV-infected patients are allowed
Exclusion criteria
High level of resistance to doravirine according to historical resistance tests. * Level of resistance to doravirine superior to that of etravirine * Opportunistic or serious active infection or disease * Active and untreated malignancy. * Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures * Pregnancy. * Active treatment for hepatitis C is forbidden at entry but will be allowed after 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects who maintain virologic control . | 24 weeks | Virologic control is defined by measurement of HIV-1 RNA \< 50 copies/mL. |
Countries
Canada, Martinique
Contacts
Primary ContactIoannis vertzagias
Backup Contactbenoit trottier, MD
Outcome results
None listed