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 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT02659761
Eligibility Criteria:
Inclusion Criteria:
* HIV-infected adults (≥18 years of age) with a history of IDU as the principal HIV transmission risk factor or with current or recent (past 12 months) history of IDU
* Either currently receiving an antiretroviral regimen but experiencing adherence or tolerability issues on current ART or restarting ART after an unscheduled treatment interruption
* Willing to switch current ART regimen
* No documented viral resistance to currently licensed HIV-1 integrase inhibitors, abacavir and lamivudine based either on previous HIV-1 genotypic resistance testing or in the judgment of the study investigators
* Integrase inhibitor naïve (defined as no-prior exposure to any INSTI)
* Documented negative HLAB\*5701 allele
Exclusion Criteria:
* Subjects with active hepatitis B infection (defined as hepatitis B surface antigen (sAg) positive)
* Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
* Chronic renal failure estimated by glomerular filtration rate (eGFR) \<60mls/min/1.73m2 at screening using the abbreviated Modification of Diet in Renal Disease (MDRD) equation
* Any active illness (including AIDS-defining illness) which in the opinion of the investigator would prevent the subject from completing all study assessments
* Female subjects who are pregnant, breastfeeding or planning future pregnancies or unwilling to take measures to avoid pregnancy for the study duration
* Any grade 4 laboratory abnormalities
* Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification
* Subjects weighing less than 40 kilograms and those are likely to require a Triumeq dose adjustment
* History or presence of allergy to the study drug or their components
* A diagnosis of cancer under current active chemotherapy or radiotherapy or having received chemotherapy or radiotherapy for a diagnosis of cancer within the previous 21 days prior to screening
* Subjects with a documented HLAB\*5701 positive test on archived or screening bloods
* Concurrent use of any contraindicated medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02659761
Study Brief:
Protocol Section:
NCT02659761