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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT04150068
Eligibility Criteria:
Key Inclusion Criteria:
* Adult aged ≥ 18 years (at all sites) or adolescent aged ≥ 12 and weighing ≥ 35 kg (at sites in North America and Dominican Republic)
* Currently receiving a stable failing ARV regimen for \> 8 weeks
* Have HIV-1 RNA ≥ 400 copies/mL at screening
* Have multidrug resistance (resistance to ≥2 agents from ≥3 of the 4 main classes of ARV)
* Have no more than 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen
* Able and willing to receive an OBR together with lenacapavir
* No Hepatitis C virus (HCV) ongoing infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04150068
Study Brief:
Protocol Section:
NCT04150068