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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02659761
Other study ID # TAISTR_2016
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date November 2016
Est. completion date September 2021

Study information

Verified date May 2024
Source University College Dublin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 of ART.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Ireland Mater Misericordiae University Hospital Dublin

Sponsors (3)

Lead Sponsor Collaborator
University College Dublin Mater Misericordiae University Hospital, ViiV Healthcare

Country where clinical trial is conducted

Ireland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Tolerability as assessed by the number of subjects with treatment-related adverse events measured using a self-reported form and directed symptoms questionnaire Measured through 96 weeks
Primary Proportion of subjects with unscheduled discontinuation of study treatment Measured through 96 weeks
Primary Change in medication possession ratio (MPR) at 48 weeks or adherence score as measured by an antiretroviral therapy medication self-report form Measured through 48 weeks
Primary Proportion of subjects with HIV RNA<40 cps/ml at 48 weeks Measured through 48 weeks
Secondary Change in number and severity of ART-related adverse effects Measured through 48 weeks; 96 weeks
Secondary Change in health-related quality of life (HRQOL) Measured through 48 weeks; 96 weeks
Secondary Change in frailty score Measured through 48 weeks; 96 weeks
Secondary Estimated number of weeks of missed ART Measured through 48 weeks; 96 weeks
Secondary 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 through 96 weeks
Secondary Proportion of subjects with HIV RNA<40 copies/mL At 96 weeks
Secondary Change in the number of drug resistant mutations in subjects experiencing virological failure Measured through 96 weeks
Secondary Change in bone mineral density Measured through 96 weeks
Secondary Number of subjects with any adverse and any serious adverse events (SAE) and/or grade 1 to 4 laboratory abnormalities Measured through 96 weeks
Secondary Change in CD4+ T-cell count Measured through 96 weeks
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