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:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT05495204
Eligibility Criteria:
Inclusion Criteria (Trial IBA+OBR group):
* Participant in TMB-202 or TMB-301/311
* Received 800 mg IBA every 2 weeks, with or without a loading dose
Inclusion Criteria (OPERA non-IBA OBR group):
* HIV-1 infection
* 18 years or older
* Heavily treatment experienced (i.e., ever on a regimen containing either DTG BID or DRV BID)
* Documented resistance to ≥1 ARV from each of three ARV classes
* Genotype information available for all the relevant gene regions (see Table 2)
* Viral load \> 200 copies/mL at index regimen initiation
* Not pregnant at index
* No new AIDS defining event within 3 months before/on index (except cutaneous Kaposi's sarcoma or HIVAW)
* No new cancer diagnosis within 12 weeks before/on index
* No IBA prescribed prior to/with the index regimen
* Index regimen does not include cabotegravir, fostemsavir, investigational drugs
* Viral sensitivity/susceptibility to at least one ARV in the index regimen
* Baseline VL available (within 6 months before/at index)
* Baseline CD4 available (within 6 months before/at index)
* ≥1 VL measurement at any time after index
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05495204
Study Brief:
Protocol Section:
NCT05495204