HIVSINNRNCT02306577
STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY)
An observational study of HIV and Illicit Drug User, run by Vancouver Infectious Diseases Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- HIV, Illicit Drug User
- What is being tested?
- STRIBILD
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected people who are current or past illicit drug users and receive treatment for their HIV infection
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, V6Z 2C7
Harout Tossonian, MD, PhD, 604-642-6429 ext. 304, Harout.Tossonian@vidc.ca
Syune Hakobyan, MD, MHSc, 604-642-6429 ext. 308, Syune.Hakobyan@vidc.ca
About this study
Official title: STRIBILD in Non-Nucleoside Resistant Patients, An Evaluation of Safety and Efficacy in Vulnerable Population (SINNR STUDY)
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.
Read the 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.
- Conditions
- HIV, Illicit Drug User
- Being tested
- STRIBILD
- Keywords
- STRIBILD, HIV, Illicit dgug user
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRIBILDDrug
Taking oral 1 STRIBILD tablet once a day for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: STRIBILD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic Efficacy (viral load <50copies/ml after taking STRIBILD)
Evaluate viral load <50copies/ml after taking STRIBILD
Measured: 48 weeks
Secondary outcomes (4)
Safety-Side Effect Profile and Number of Participants with Adverse Events
Evaluate safety of STRIBILD
Measured: 48 weeks
Immunologic Response-CD4 Cell Count and Change in CD4 Cell Count at 48 Weeks
Evaluate immunologic response of STRIBILD
Measured: 48 weeks
Adherence
Evaluate Adherence to STRIBILD
Measured: 48 weeks
Quality of Life
Evaluate Quality of life after taking STRIBILD
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Infectious Diseases Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Regina General Hospital
- Responsible party
- Sponsor
- Investigators
- Brian Conway, MD, Principal investigator, Vancouver ID Research and Care Centre Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306577
- Sponsor's protocol ID
- SINNR STUDY
- Acronym
- SINNR
- Status last verified
- Jun 2015
- First submitted
- 5 Nov 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRIBILD in Non-Nucleoside Resistant Patients, An Evaluation of Safety and Efficacy in Vulnerable Population (SINNR STUDY)
- ClinicalTrials.gov ID
- NCT02306577
- Acronym / sponsor ID
- SINNR / SINNR STUDY
- Conditions
- HIV, Illicit Drug User
- Keywords
- STRIBILD, HIV, Illicit dgug user
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vancouver Infectious Diseases CentreUniversity, hospital or other
- Collaborators
- Gilead Sciences, Regina General Hospital
- Study start
- Nov 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vancouver | – | Drug: STRIBILDHIV 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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected people who are current or past illicit drug users and receive treatment for their HIV infection
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIBILDTaking oral 1 STRIBILD tablet once a day for 48 weeks | Drug | Vancouver |
Primary outcome
Virologic Efficacy (viral load <50copies/ml after taking STRIBILD)
Time frame: 48 weeks
Evaluate viral load <50copies/ml after taking STRIBILD
4 secondary outcomes
Safety-Side Effect Profile and Number of Participants with Adverse Events
Time frame: 48 weeks
Immunologic Response-CD4 Cell Count and Change in CD4 Cell Count at 48 Weeks
Time frame: 48 weeks
Adherence
Time frame: 48 weeks
Quality of Life
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Conway, MD principal investigator
Vancouver ID Research and Care Centre Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Illicit Drug User, run by Vancouver Infectious Diseases Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harout Tossonian, MD, PhD (604-642-6429 ext. 304, Harout.Tossonian@vidc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virologic Efficacy (viral load <50copies/ml after taking STRIBILD) (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.