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

NCT02659761 | Terminated Phase 4 DMC

• 1 other identifier: TAISTR_2016
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus

Keywords

Human Immunodeficiency Virus; Injection drug use; Single-tablet antiretroviral treatment; Dolutegravir; Tolerability; Adherence; Efficacy

Outcome Measures

Primary Outcomes (4)

• Tolerability as assessed by the number of subjects with treatment-related adverse events measured using a self-reported form and directed symptoms questionnaire

  Measured through 96 weeks

• Proportion of subjects with unscheduled discontinuation of study treatment

  Measured through 96 weeks

• Change in medication possession ratio (MPR) at 48 weeks or adherence score as measured by an antiretroviral therapy medication self-report form

  Measured through 48 weeks

• Proportion of subjects with HIV RNA<40 cps/ml at 48 weeks

  Measured through 48 weeks

Secondary Outcomes (10)

• Change in number and severity of ART-related adverse effects

  Measured through 48 weeks; 96 weeks

• Change in health-related quality of life (HRQOL)

  Measured through 48 weeks; 96 weeks

• Change in frailty score

  Measured through 48 weeks; 96 weeks

• Estimated number of weeks of missed ART

  Measured through 48 weeks; 96 weeks

• Change from baseline in medication possession ratio (MPR) at 96 weeks or adherence score as measured by an antiretroviral therapy medication self-report form

  Measured through 96 weeks

Study Arms (1)

dolutegravir/abacavir/lamivudine

EXPERIMENTAL

All study subjects will receive triumeq (600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine) single tablet that will be taken orally, once daily, during 96 weeks

Drug: dolutegravir/abacavir/lamivudine

Interventions

dolutegravir/abacavir/lamivudine DRUG

600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine single tablet taken orally, once daily, during 96 weeks

Also known as: Triumeq

dolutegravir/abacavir/lamivudine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• Mater Misericordiae University Hospital: collaborator
• ViiV Healthcare: collaborator

Study Sites (1)

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

Related Publications (2)

• Cohn SE, Jiang H, McCutchan JA, Koletar SL, Murphy RL, Robertson KR, de St Maurice AM, Currier JS, Williams PL. Association of ongoing drug and alcohol use with non-adherence to antiretroviral therapy and higher risk of AIDS and death: results from ACTG 362. AIDS Care. 2011 Jun;23(6):775-85. doi: 10.1080/09540121.2010.525617.

  PMID: 21293986 BACKGROUND

• Meemken L, Hanhoff N, Tseng A, Christensen S, Gillessen A. Drug-Drug Interactions With Antiviral Agents in People Who Inject Drugs Requiring Substitution Therapy. Ann Pharmacother. 2015 Jul;49(7):796-807. doi: 10.1177/1060028015581848. Epub 2015 Apr 22.

  PMID: 25902733 BACKGROUND

Related Links

• Centre for Experimental Host Pathogen Research

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

abacavir, dolutegravir, and lamivudine drug combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Patrick Mallon, MB BCh, PhD, FRCPI

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 20, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

IE (1)