MedDRA - HIV-1 B20-B24
Conditions
Interventions
Group 1: HIV-1 patients (f/m//d) that have been switched from another antiretroviral therapy to a Doravirine based antiretroviral therapy and fulfill the inclusion criteria.
This will be a non-interve
Sponsors
Merck Sharp & Dohme LLC., eine Tochtergesellschaft von Merck & Co., Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years at the time ART was switched to include Doravirine 2. Confirmed HIV-1 infection (positive HIV-1 test as per clinical routine, e.g. PCR test or positive antibody test) 3. On non-Doravirine based antiretroviral therapy at the time of switch with at least 2 consecutive viral load measurements of <50 copies/mL within 6 months prior to switching to Doravirine based antiretroviral therapy 4. Having switched to Doravirine based antiretroviral therapy as part of a 2 or 3 drug combination 4a. Patients will be considered for enrollment after the decision to prescribe DOR has already been made 5. Retrospective dataset with treatment history 6. Patient has signed written informed consent
Exclusion criteria
Exclusion criteria: 1. Antiretroviral therapy since switch to Doravirine based antiretroviral therapy contained any drug without marketing authorization (i.e. patient participated in an interventional clinical trial on ARTs) or patient is currently enrolled in any other interventional clinical trial 2. Pregnancy at the time switching to Doravirine based antiretroviral therapy and 12 months prior to switch 3. Among those patients switched to DOR/TDF/3TC, documented CrCl <50 mL/min at time of switch 4. Among those patients switched to DOR/TDF/3TC, documented end-stage renal disease or undergoing dialysis at the time of switch 5. Among those patients with NNRTI mutations, documented doravirine resistance associated mutations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with HIV-1 RNA < 50 copies/ml at 12 months, or if between 50-200 copies/ml at 12 months, with a subsequent next available measurement < 50 copies/ml (within 120 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary and exploratory outcomes: - CD4+ T cell counts - baseline comorbidities and comedications - reasons for switching to DOR-based ART - durability on DOR-based ART - BMI and body weight - lipids - serum creatinine and eGFR | — |
Countries
Germany
Contacts
Public ContactJann-Patrick Pelz
MSD SHARP & DOHME GmbH
Outcome results
None listed