STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY) (SINNR)

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

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.

Study Overview

• Status: Unknown
• Conditions: HIV; Illicit Drug User
• Intervention / Treatment: Drug: STRIBILD

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Recruiting
      • Vancouver ID Research and Care Centre Society
      • Principal Investigator: Brian Conway, MD
      • Contact: Harout Tossonian, MD, PhD; Phone Number: 304 604-642-6429; Email: Harout.Tossonian@vidc.ca
      • Contact: Syune Hakobyan, MD, MHSc; Phone Number: 308 604-642-6429; Email: Syune.Hakobyan@vidc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV infected people who are current or past illicit drug users and receive treatment for their HIV infection

Description

Inclusion Criteria:

1. 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.
2. Participant has documented resistance to NNRTIs, with the presence of one or more primary resistance mutations (Stanford database), on current or previous therapy.
3. The primary care provider decides to prescribe STRIBILD.
4. 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.
5. Participant is able to read and write in the language of the questionnaires and give informed consent.
6. Participant must not be taking any medication that could interact with STRIBILD.
7. 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:

1. Participant has previous exposure to STRIBILD.
2. Participant has documented resistance to any of the components of STRIBILD.
3. Participant is pregnant or breast-feeding.
4. Participant has a contraindication to the use of STRIBILD for any reason.
5. Participant has active hepatitis B (HbsAg positive).

6. 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.

7. Participant, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vancouver; 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; Taking oral 1 STRIBILD tablet once a day for 48 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vancouver Infectious Diseases Centre
• Collaborators: Gilead Sciences; Regina General Hospital
• Investigators: Principal Investigator: Brian Conway, MD, Vancouver ID Research and Care Centre Society

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: November 5, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: HIV; STRIBILD; Illicit dgug user
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: SINNR STUDY