TerminatedPhase 4

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

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

Ireland33 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 abnorm…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Measured through 96 weeks

Proportion of subjects with unscheduled discontinuation of study treatment

Timeframe: 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

Timeframe: Measured through 48 weeks

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

Timeframe: Measured through 48 weeks

Trial details

NCT IDNCT02659761

SponsorUniversity College Dublin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09

View on ClinicalTrials.gov More Human Immunodeficiency Virus trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Measured through 96 weeks

Proportion of subjects with unscheduled discontinuation of study treatment

Timeframe: 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

Timeframe: Measured through 48 weeks

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

Timeframe: Measured through 48 weeks