STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY)

Vancouver Infectious Diseases Centre

Status: Unknown

Conditions: HIV; Illicit Drug User

Treatments: Drug: STRIBILD

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02306577

SINNR STUDY

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Vancouver

Description:

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.

Treatment:

Drug: STRIBILD