STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY) | NCT02306577

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

NCT02306577

Sponsor

Vancouver Infectious Diseases Centre

Status

Unknown status

Last Update Posted

Jun 3, 2015Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

HIV
Illicit Drug User

Interventions

STRIBILD

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Nov 5, 2014

First Submission Date that Met QC Criteria

Nov 28, 2014

First Posted Date

Dec 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Name	Class
Gilead Sciences	INDUSTRY
Regina General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
STRIBILD	Drug	Taking oral 1 STRIBILD tablet once a day for 48 weeks	Vancouver

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Harout Tossonian, MD, PhD	Contact	604-642-6429	304	Harout.Tossonian@vidc.ca
Syune Hakobyan, MD, MHSc	Contact	604-642-6429	308	Syune.Hakobyan@vidc.ca

ID	Term
D000069547	Cobicistat
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids