TerminatedNCT02659761TAISTRUpdated May 9, 2024

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

A Phase 4 interventional study of dolutegravir/abacavir/lamivudine in Human Immunodeficiency Virus, sponsored by University College Dublin. Terminated at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University College Dublin · Phase 4, Interventional, and Treatment

Why this study was terminated

Sponsor decision due to slow recruitment rates and no future recruitment foreseen

Phase: Phase 4
Study type: Interventional
Enrollment: 33
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

Dolutegravir (DTG) is an integrase strand transfer inhibitor (INSTI) that supports once-daily dosing without the need for pharmacokinetic boosting and may be co-formulated with other antiretrovirals into a single-tablet regimen (STR). With people living with HIV with injection drug use (IDU) being more prone to unplanned antiretroviral therapy (ART) discontinuation and suboptimal adherence, DTG offers a high genetic barrier to resistance, a profile that reduces drug-drug interactions, with better tolerability and its availability as single tablet regimen (STR) combined with abacavir and lamivudine (ABC/3TC) is likely to improve adherence.

The aims of this study include:

To assess tolerability through self-reported adverse effects and directed symptom questionnaire
To determine change in number and severity of reported ART-related adverse effects from baseline to week 48 and 96
To determine change in health-related quality of life (HRQOL) from baseline to week 48 and 96
To determine change in frailty score from baseline to week 48 and 96
To determine the percentage of subject with unscheduled ART discontinuations/ interruptions over 96 weeks
To determine the estimated number of weeks of missed ART over 48 and 96 weeks of follow-up
To determine change from baseline of medication possession ratio (MPR) at 48 and 96 weeks or adherence score as measured by an antiretroviral therapy medication self-report form at the same time points
To determine the percentage of subjects with HIV RNA\<40 copies/mL at 96 weeks
To determine change in genotypic resistance profiles in subjects experiencing virological failure
To determine change in CD4+ T-cell counts through 96 weeks
To determine change in bone mineral density through 96 weeks
To determine the number of subjects with any adverse and any serious adverse events (SAE) from baseline to week 96
To determine the number of subject with Grade 1 to 4 laboratory abnormalities from baseline to week 96

This is a prospective, single arm, open-label 96 weeks clinical trial. Study subjects will be followed for 96 weeks post enrolment, with regular clinical evaluations, laboratory evaluations, safety and adherence assessment, quality of life and bone mineral density (BMD) measured at regular intervals.

Conditions studied

Human Immunodeficiency Virus

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Keywords

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

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 33 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

University College Dublin is the lead sponsor of 108 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 33 participants (actual)

Study arms

Experimental
dolutegravir/abacavir/lamivudine
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

Drugdolutegravir/abacavir/lamivudine
600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine single tablet taken orally, once daily, during 96 weeks
Also known as: Triumeq

What researchers measure

Primary outcomes

Tolerability as assessed by the number of subjects with treatment-related adverse events measured using a self-reported form and directed symptoms questionnaire
Time frame: Measured through 96 weeks
Proportion of subjects with unscheduled discontinuation of study treatment
Time frame: 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
Time frame: Measured through 48 weeks
Proportion of subjects with HIV RNA<40 cps/ml at 48 weeks
Time frame: Measured through 48 weeks

Secondary outcomes

Change in number and severity of ART-related adverse effects
Time frame: Measured through 48 weeks; 96 weeks
Change in health-related quality of life (HRQOL)
Time frame: Measured through 48 weeks; 96 weeks
Change in frailty score
Time frame: Measured through 48 weeks; 96 weeks
Estimated number of weeks of missed ART
Time frame: 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
Time frame: Measured through 96 weeks
Proportion of subjects with HIV RNA<40 copies/mL
Time frame: At 96 weeks
Change in the number of drug resistant mutations in subjects experiencing virological failure
Time frame: Measured through 96 weeks
Change in bone mineral density
Time frame: Measured through 96 weeks
Number of subjects with any adverse and any serious adverse events (SAE) and/or grade 1 to 4 laboratory abnormalities
Time frame: Measured through 96 weeks
Change in CD4+ T-cell count
Time frame: Measured through 96 weeks

Study locations

1 site

Mater Misericordiae University Hospital
Dublin, 7, Ireland

References and documents

Publications

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. PubMed 21293986 ↗
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. PubMed 25902733 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02659761
Lead sponsor: University College Dublin
Collaborators: Mater Misericordiae University Hospital, ViiV Healthcare
Responsible party: Sponsor
First posted: Jan 20, 2016
Start date: Nov 2016
Primary completion: Sep 2021
Completion: Sep 2021
Last update: May 9, 2024

Study contacts

Patrick Mallon, MB BCh, PhD, FRCPI

principal investigator · University College Dublin

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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