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Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified October 2016 by University College Dublin

Sponsor
University College Dublin

Collaborator
Mater Misericordiae University Hospital
ViiV Healthcare

Information provided by (Responsible Party)
University College Dublin
ClinicalTrials.gov Identifier
NCT02659761

First received: January 8, 2016
Last updated: October 24, 2016
Last Verified: October 2016
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Human Immunodeficiency Virus

Drug : dolutegravir/abacavir/lamivudine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by University College Dublin:

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 [ 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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

Other Name: Triumeq

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02659761

Contacts

Contact:   Willard Tinago, PhD wtinago@gmail.com
Contact:   Alan Macken, BA alan.macken@ucd.ie

Locations

Ireland
Mater Misericordiae University Hospital
Dublin, Ireland, 7

Sponsors and Collaborators

University College Dublin
Mater Misericordiae University Hospital
ViiV Healthcare

Investigators

Principal Investigator: Patrick Mallon, MB BCh, PhD, FRCPI University College Dublin
More Information

More Information

Additional Information:

HIV Molecular Research Group (HMRG)

Responsible Party: University College Dublin  
ClinicalTrials.gov Identifier: NCT02659761   History of Changes  
Other Study ID Numbers: TAISTR_2016  
Study First Received: January 8, 2016  
Last Updated: October 24, 2016  

Keywords provided by University College Dublin:

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

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Lamivudine
Abacavir
Dideoxynucleosides
Dolutegravir

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.