Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT05421806
Eligibility Criteria:
Inclusion Criteria:
* are HIV positive male or female
* are aged ≥18 years
* were prescribed and received at least one dose of DOR (without initial dose adjustment).
* have started/been switched to DOR for at least 12 months at time of data collection
* had a resistance genotype available before starting DOR
* had no evidence of DOR-associated resistance mutation
* were on DOR containing ART regimen that also contained 2 fully active nucleos(t)ides and patient had no documented NRTI resistance mutations to the two NRTIs in the combination.
* Patients who, at the time of initiation, were:
1. Category 1: HIV treatment naïve OR
2. Category 2: Virologically suppressed (HIV-1 RNA \<50 copies/mL) for at least 6 months with no evidence of prior virological failure with agents of the NNRTI class
Patients in category 1 and 2 above who have NNRTI mutations that do not impact on DOR (K103N, Y181C, and G190A) using the Stanford algorithm (https://hivdb.stanford.edu/hivdb/by-mutations) can be included in this study.
Exclusion Criteria:
* Patients who have DOR as part of their fourth line or higher therapy
* Patients with prior virological failure with agents of the NNRTI class
* Patients with no documented resistance testing.
* Patients with no genotype available at DOR initiation
* Patients enrolled in DOR trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05421806
Study Brief:
Protocol Section:
NCT05421806