Triumeq As an Integrase Single Tablet Regimen in People with HIV who Inject Drugs

Phase 1

• Conditions: Human Immunodeficiency Virus (HIV) infection; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2016-000087-42-ES
• Lead Sponsor: niversity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•HIV1-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 ART naïve or currently receiving an antiretroviral regimen but experiencing problems with adherence or tolerability issues on current ART therapy 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 (with the exception of M184V) 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Anticipated need for hepatitis C (defined as hepatitis C antibody (Ab) and RNA positive) treatment during the first 24 weeks of the study and 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 defined as eGFR<60mls/min/1.73m2 at screening using the abbreviated Modification of Diet in Renal Disease (MDRD) equation: eGFR (ml/min/1,73 m2) = 175 x (CrS) -1,154 x (age)-0,203 x 0,742 (if female) x 1,21 (if black)
•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 at screening
•Alanine aminotransferase (ALT) ?5 times the upper limit of normal (ULN), OR ALT ?3xULN and bilirubin ?1.5xULN (with >35% direct bilirubin);
•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 (see section 5.2.2)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified