Human Immunodeficiency VirusPhase 4TAISTRNCT02659761

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

A Phase 4 study testing dolutegravir/abacavir/lamivudine in people with Human Immunodeficiency Virus, run by University College Dublin at 1 site in Ireland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: dolutegravir/abacavir/lamivudine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteIreland
Study dates: Nov 2016to Sep 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

Ireland1 site

Mater Misericordiae University Hospital
Dublin, 7

Other trials in Ireland

About this study

Official title: A Prospective, Single Arm, Open-label 96 Week Observational Trial of the Tolerability, Adherence and Efficacy of a Dolutegravir/Abacavir/Lamivudine Single Tablet Regimen in HIV-1 Antibody Positive People Living With HIV With a History of Injection Drug Use Switching From Existing 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: Human Immunodeficiency Virus
Being tested: dolutegravir/abacavir/lamivudine
Keywords: Human Immunodeficiency Virus, Injection drug use, Single-tablet antiretroviral treatment, Dolutegravir, Tolerability, Adherence, Efficacy
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dolutegravir/abacavir/lamivudineDrug
Also called Triumeq
600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine single tablet taken orally, once daily, during 96 weeks

Study groups in NCT02659761
Study group	Role	What they receive
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 Receives: Drug: dolutegravir/abacavir/lamivudine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Sep 2021

First posted20 Jan 2016 (estimated)
Study startNov 2016
Primary completionSep 2021
Study completionSep 2021

Why it stopped: Sponsor decision due to slow recruitment rates and no future recruitment foreseen

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

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

IDs, dates and publications

ClinicalTrials.gov ID: NCT02659761
Sponsor's protocol ID: TAISTR_2016
Acronym: TAISTR
Status last verified: May 2024
First submitted: 8 Jan 2016
Last updated: 9 May 2024
Results posted: No
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Single Arm, Open-label 96 Week Observational Trial of the Tolerability, Adherence and Efficacy of a Dolutegravir/Abacavir/Lamivudine Single Tablet Regimen in HIV-1 Antibody Positive People Living With HIV With a History of Injection Drug Use Switching From Existing ART or Starting Treatment After Discontinuation of ART
ClinicalTrials.gov ID: NCT02659761
Acronym / sponsor ID: TAISTR / TAISTR_2016
Conditions: Human Immunodeficiency Virus
Keywords: Human Immunodeficiency Virus, Injection drug use, Single-tablet antiretroviral treatment, Dolutegravir, Tolerability, Adherence, Efficacy
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision due to slow recruitment rates and no future recruitment foreseen
Enrolment: 33 participants (actual)
Lead sponsor: University College DublinUniversity, hospital or other
Collaborators: Mater Misericordiae University Hospital, ViiV Healthcare
Study start: Nov 2016 (actual)
Primary completion: Sep 2021 (actual)
Study completion: Sep 2021 (actual)
First posted: 20 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
dolutegravir/abacavir/lamivudine	Experimental	Drug: dolutegravir/abacavir/lamivudineAll 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dolutegravir/abacavir/lamivudineAlso: Triumeq600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine single tablet taken orally, once daily, during 96 weeks	Drug	dolutegravir/abacavir/lamivudine

Primary outcome

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

10 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

Results and safety

The study was stopped early (reason given: Sponsor decision due to slow recruitment rates and no future recruitment foreseen). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Background: PubMed 21293986Cohn 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.
Background: PubMed 25902733Meemken 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick Mallon, MB BCh, PhD, FRCPI principal investigator

University College Dublin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dolutegravir/abacavir/lamivudine in people with Human Immunodeficiency Virus, run by University College Dublin at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision due to slow recruitment rates and no future recruitment foreseen). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02659761, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.