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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SSAT064: Pharmacokinetics of Abacavir/Lamivudine/Dolutegravir in HIV Patients of 60 Years and Over

NCT02509195

HIV

COMPLETED PHASE4

Abacavir, Dolutegravir and Lamivudine Dispersible Tablets (60 mg/5 mg/30 mg)

NCT05030025

HIV-1-infection

COMPLETED EARLY_PHASE1

Bioequivalence Study of CRushed TriUMeq With or Without Drip Feed Compared to the Whole Tablet

NCT02569346

HIV

COMPLETED PHASE1

A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents

NCT00915655

HIV-1 Infection

COMPLETED PHASE2

FREE Study: Efficacy and Toxicity of Trizivir

NCT00405925

HIV Infections

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

dolutegravir/abacavir/lamivudine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dolutegravir/abacavir/lamivudine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Triumeq

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No