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 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT03754803
Eligibility Criteria:
Inclusion Criteria:
* Participants \>= 18 years of age.
* Participants with documented HIV-1 infection.
* Prescription of DTG + 3TC was issued independently from entering this study.
* Participants with the ability to understand informed consent form and other relevant regulatory documents.
Exclusion Criteria:
* Any contraindication according to Tivicay or Lamivudine summaries of product characteristics (SmPCs).
* Participants with VL \> 500 c/mL.
* Any antiretroviral therapy for the treatment of HIV-1 in addition to DTG and 3TC or the DTG/3TC fixed dose combination (FDC).
* Participants with hepatitis B virus (HBV)- coinfection.
* Participants with current participation in the ongoing non-interventional study TRIUMPH (study number: 202033, NCT number: NCT02342769) or in any interventional clinical trial irrespective of indication.
* Participants who had previously participated in clinical trials assessing DTG+ 3TC.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03754803
Study Brief:
Protocol Section:
NCT03754803