STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY)

HIV Clinical Trial

— SINNR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306577
• Other study ID #: SINNR STUDY
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2014
• Last updated: June 1, 2015
• Start date: November 2014
• Est. completion date: July 2016

Study information

• Verified date: June 2015
• Source: Vancouver Infectious Diseases Centre
• Contact: Harout Tossonian, MD, PhD
• Phone: 604-642-6429
• Email: Harout.Tossonian[@]vidc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV
• Illicit Drug User

Intervention

Drug:
• STRIBILD
Taking oral 1 STRIBILD tablet once a day for 48 weeks

Locations

Country	Name	City	State
Canada	Vancouver ID Research and Care Centre Society	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Vancouver Infectious Diseases Centre	Gilead Sciences, Regina General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic Efficacy (viral load <50copies/ml after taking STRIBILD)	Evaluate viral load <50copies/ml after taking STRIBILD	48 weeks	No
Secondary	Safety-Side Effect Profile and Number of Participants with Adverse Events	Evaluate safety of STRIBILD	48 weeks	No
Secondary	Immunologic Response-CD4 Cell Count and Change in CD4 Cell Count at 48 Weeks	Evaluate immunologic response of STRIBILD	48 weeks	No
Secondary	Adherence	Evaluate Adherence to STRIBILD	48 weeks	No
Secondary	Quality of Life	Evaluate Quality of life after taking STRIBILD	48 weeks	No