Recruiting

STRIBILD

Sponsor:

Vancouver Infectious Diseases Centre

Code:

NCT02306577

Conditions

HIV

Illicit Drug User

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Not accepted

Interventions

STRIBILD

Study Details

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.

Conditions

HIV

Illicit Drug User

Study ID

NCT02306577

Start date

Nov, 2014

Status verified date

Jun, 2015

Completion date

Jul, 2016

Anticipated

Primary completion date

Apr, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

STRIBILD

Taking oral 1 STRIBILD tablet once a day for 48 weeks

Primary outcome measure

  • Virologic Efficacy (viral load <50copies/ml after taking STRIBILD) [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Harout Tossonian, MD, PhD

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

Syune Hakobyan, MD, MHSc

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

Locations

Vancouver ID Research and Care Centre Society

Recruiting

Vancouver, British Columbia, Canada, V6Z 2C7

Contacts

Harout Tossonian, MD, PhD

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

Syune Hakobyan, MD, MHSc

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

Principal Investigator:

Brian Conway, MD

More Information

Sponsor

Vancouver Infectious Diseases Centre

Last update posted

Jun 3, 2015

Last verified

Jun, 2015

Keywords

  • STRIBILD
  • HIV
  • Illicit dgug user

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver Infectious Diseases Centre on 2015-06-03.