NCT02306577

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

November 5, 2014

Last Update Submit

June 1, 2015

Conditions

HIVIllicit Drug User

Keywords

STRIBILDHIVIllicit dgug user

Outcome Measures

Primary Outcomes (1)

  • Virologic Efficacy (viral load <50copies/ml after taking STRIBILD)

    Evaluate viral load \<50copies/ml after taking STRIBILD

    48 weeks

Secondary Outcomes (4)

  • Safety-Side Effect Profile and Number of Participants with Adverse Events

    48 weeks

  • Immunologic Response-CD4 Cell Count and Change in CD4 Cell Count at 48 Weeks

    48 weeks

  • Adherence

    48 weeks

  • Quality of Life

    48 weeks

Study Arms (1)

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

Interventions

STRIBILDDRUG

Taking oral 1 STRIBILD tablet once a day for 48 weeks

Vancouver

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver ID Research and Care Centre Society

Vancouver, British Columbia, V6Z 2C7, Canada

RECRUITING

MeSH Terms

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

CobicistatCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsTenofovirOrganophosphonatesOrganophosphorus CompoundsThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Brian Conway, MD

    Vancouver ID Research and Care Centre Society

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harout Tossonian, MD, PhD

CONTACT

604-642-6429Harout.Tossonian@vidc.ca

Syune Hakobyan, MD, MHSc

CONTACT

604-642-6429Syune.Hakobyan@vidc.ca

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

December 3, 2014

Study Start

November 1, 2014

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

CA(1)