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

Primary Purpose

Human Immunodeficiency Virus

Status

Unknown status

Phase

Phase 4

Locations

Ireland

Study Type

Interventional

Intervention

dolutegravir/abacavir/lamivudine

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Human Immunodeficiency Virus, Injection drug use, Single-tablet antiretroviral treatment, Dolutegravir, Tolerability, Adherence, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mater Misericordiae University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dolutegravir/abacavir/lamivudine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Proportion of subjects with unscheduled discontinuation of study treatment

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

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

Secondary Outcome Measures

Change in number and severity of ART-related adverse effects

Change in health-related quality of life (HRQOL)

Change in frailty score

Estimated number of weeks of missed ART

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

Proportion of subjects with HIV RNA<40 copies/mL

Change in the number of drug resistant mutations in subjects experiencing virological failure

Change in bone mineral density

Number of subjects with any adverse and any serious adverse events (SAE) and/or grade 1 to 4 laboratory abnormalities

Change in CD4+ T-cell count

Full Information

NCT ID

NCT02659761

First Posted

January 8, 2016

Last Updated

April 25, 2019

Sponsor

University College Dublin

Collaborators

Mater Misericordiae University Hospital, ViiV Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT02659761

Brief Title

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

Acronym

TAISTR

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University College Dublin

Collaborators

Mater Misericordiae University Hospital, ViiV Healthcare

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dolutegravir/abacavir/lamivudine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

dolutegravir/abacavir/lamivudine

Other Intervention Name(s)

Triumeq

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

Proportion of subjects with unscheduled discontinuation of study treatment

Time Frame

Measured through 96 weeks

Title

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

Title

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

Time Frame

Measured through 48 weeks

Secondary Outcome Measure Information:

Title

Change in number and severity of ART-related adverse effects

Time Frame

Measured through 48 weeks; 96 weeks

Title

Change in health-related quality of life (HRQOL)

Time Frame

Measured through 48 weeks; 96 weeks

Title

Change in frailty score

Time Frame

Measured through 48 weeks; 96 weeks

Title

Estimated number of weeks of missed ART

Time Frame

Measured through 48 weeks; 96 weeks

Title

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

Title

Proportion of subjects with HIV RNA<40 copies/mL

Time Frame

At 96 weeks

Title

Change in the number of drug resistant mutations in subjects experiencing virological failure

Time Frame

Measured through 96 weeks

Title

Change in bone mineral density

Time Frame

Measured through 96 weeks

Title

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

Title

Change in CD4+ T-cell count

Time Frame

Measured through 96 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Willard Tinago, PhD

wtinago@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Alan Macken, BA

alan.macken@ucd.ie

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Mallon, MB BCh, PhD, FRCPI

Organizational Affiliation

University College Dublin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mater Misericordiae University Hospital

City

Dublin

ZIP/Postal Code

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Willard Tinago, PhD

wtinago@gmail.com

First Name & Middle Initial & Last Name & Degree

Patrick WG Mallon, MB BCh, PhD, FRCPI

paddy.mallon@ucd.ie

First Name & Middle Initial & Last Name & Degree

Patrick Mallon, MB BCh, PhD, FRCPI

First Name & Middle Initial & Last Name & Degree

Gerard Sheehan, MB BCh BAO, FRCPI

First Name & Middle Initial & Last Name & Degree

John Lambert, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

21293986

Citation

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.

Results Reference

background

PubMed Identifier

25902733

Citation

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.

Results Reference

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

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