Triumeq As an Integrase Single Tablet Regimen in People With HIV Who Inject Drugs

• Status: Unknown status
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the tolerability, adherence and efficacy of single tablet dolutegravir/abacavir/lamivudine antiretroviral therapy in people living with HIV with a history of injection drug use (IDU) switching from existing antiretroviral therapy (ART) or starting treatment after discontinuation of ART.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College Dublin
• Collaborators: Mater Misericordiae University Hospital; ViiV Healthcare
• Treatments: Abacavir; Dideoxynucleosides; Dolutegravir; Lamivudine; Triumeq

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