STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY)

Study Overview
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Brief Summary
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The SINNR study will evaluate the virologic efficacy (viral load <50 copies/mL)and safety of STRIBILD administered for 48 weeks to HIV-infected current or recent illicit drug users.

Detailed Description
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The SINNR study is a pilot, observational, open label study. It will evaluate the virologic efficacy (viral load <50 copies/mL), safety, and immunologic response of STRIBILD administered for 48 weeks to HIV-infected current or recent illicit drug users. Approximately 30 HIV-infected current or recent illicit drug users (≥19y.o.,<70y.o.) from Vancouver Infectious Diseases Centre and Regina General Hospital, University of Saskatchewan will be taking an oral 1 STRIBILD tablet once a day for 48 weeks. Additionally, adherence to STRIBILD over 48 weeks and quality of life will be measured in this population.

Official Title
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STRIBILD in Non-Nucleoside Resistant Patients, An Evaluation of Safety and Efficacy in Vulnerable Population (SINNR STUDY)

Conditions
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HIV, Illicit Drug User

Intervention / Treatment
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* Drug: STRIBILD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is at least 19 years of age and less than 70 years of age infected with HIV and requiring antiretroviral therapy on medical grounds and who has acquired HIV infection through illicit drug use. Participant has documented resistance to NNRTIs, with the presence of one or more primary resistance mutations (Stanford database), on current or previous therapy. The primary care provider decides to prescribe STRIBILD. Participant has no ongoing issues that would lead to significant non-compliance with the study procedures even in the presence of optimal adherence support structures. Participant is able to read and write in the language of the questionnaires and give informed consent. Participant must not be taking any medication that could interact with STRIBILD. If female, participant must have a negative pregnancy test and agree to use, for the duration of the study, a method of birth control that has a history of proven reliability as judged by the investigator. Exclusion Criteria: Participant has previous exposure to STRIBILD. Participant has documented resistance to any of the components of STRIBILD. Participant is pregnant or breast-feeding. Participant has a contraindication to the use of STRIBILD for any reason. Participant has active hepatitis B (HbsAg positive). Participant has any of the following abnormal laboratory test results at screening: Hemoglobin less than 10.0 g/dL, Absolute neutrophil count less than 750 cells/mL, Platelet count less than 50,000/mL, ALT or AST less than 5x Upper Limit of Normal (ULN), Creatinine less than 1.5 x ULN. Participant, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vancouver<br>HIV infected people who are current of recent illicit drug users and receive Stribild for their HIV treatment at Vancouver Infectious Diseases Centre and Regina General Hospital. | Drug: STRIBILD<br>* Taking oral 1 STRIBILD tablet once a day for 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic Efficacy (viral load <50copies/ml after taking STRIBILD) | Evaluate viral load <50copies/ml after taking STRIBILD | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety-Side Effect Profile and Number of Participants with Adverse Events | Evaluate safety of STRIBILD | 48 weeks | 
| Immunologic Response-CD4 Cell Count and Change in CD4 Cell Count at 48 Weeks | Evaluate immunologic response of STRIBILD | 48 weeks | 
| Adherence | Evaluate Adherence to STRIBILD | 48 weeks | 
| Quality of Life | Evaluate Quality of life after taking STRIBILD | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, STRIBILD, Illicit dgug user