Status:
UNKNOWN
STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY)
Lead Sponsor:
Vancouver Infectious Diseases Centre
Collaborating Sponsors:
Gilead Sciences
Regina General Hospital
Conditions:
HIV
Illicit Drug User
Eligibility:
All Genders
19-70 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02306577
Start Date
November 1 2014
End Date
July 1 2016
Last Update
June 3 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada, V6Z 2C7