Clinical trial NCT03580668: Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide
Official title: Multi-center, Canadian, Non-interventional, Cohort Study of the Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adult Patients Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
Keywords: Observational
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be comprised of ART-naïve and ART-experienced HIV-1 infected adults aged ≥18 years initiating treatment with B/F/TAF in routine clinical care in Canada.

Brief summary: The primary objective of this study is to evaluate HIV-1 RNA suppression, defined as HIV-1 RNA \<50 copies/mL, at 12 months after initiating or switching to Bictegravir/ Emtricitabine/Tenofovir alafenamide (B/F/TAF).


Eligibility criteria: Inclusion Criteria:

* HIV-1 infection
* Signed informed consent
* Initiating treatment with B/F/TAF in accordance with the product monograph

Exclusion Criteria:

Participation in any other observational or interventional clinical trial without prior approval from the Medical Monitor

Primary outcomes:
measure: Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after initiating or switching to B/F/TAF
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months after initiating or switching to B/F/TAF
timeFrame: 3 months
measure: Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months after initiating or switching to B/F/TAF
timeFrame: 6 months
measure: Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months after initiating or switching to B/F/TAF
timeFrame: 24 months
measure: Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF
timeFrame: 36 months
measure: Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF
timeFrame: 48 months
measure: Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF
timeFrame: 60 months
measure: Change in CD4 Cell Count at 3 Months
timeFrame: 3 months
measure: Change in CD4 Cell Count at 6 Months
timeFrame: 6 months
measure: Change in CD4 Cell Count at 12 Months
timeFrame: 12 months
measure: Change in CD4 Cell Count at 24 Months
timeFrame: 24 months
measure: Change in CD4 Cell Count at 36 Months
timeFrame: 36 months
measure: Change in CD4 Cell Count at 48 Months
timeFrame: 48 months
measure: Change in CD4 Cell Count at 60 Months
timeFrame: 60 months
measure: CD4/CD8 Ratio at 3 Months
timeFrame: 3 months
measure: CD4/CD8 Ratio at 6 Months
timeFrame: 6 months
measure: CD4/CD8 Ratio at 12 Months
timeFrame: 12 months
measure: CD4/CD8 Ratio at 24 Months
timeFrame: 24 months
measure: CD4/CD8 Ratio at 36 Months
timeFrame: 36 months
measure: CD4/CD8 Ratio at 48 Months
timeFrame: 48 months
measure: CD4/CD8 Ratio at 60 Months
timeFrame: 60 months
measure: Proportion of Participants Experiencing Adverse Events (AEs)
timeFrame: 60 months
measure: Proportion of Participants Experiencing and Serious Adverse Events (SAEs)
timeFrame: 60 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Medicale du Quartier Latin
city: Ottawa
country: Canada
facility: University of Ottawa
city: Regina
country: Canada
facility: Regina General Hospital
city: Toronto
country: Canada
facility: St. Clair Medical Association/Balmoral Clinic
city: Toronto
country: Canada
facility: Maple Leaf Research
city: Vancouver
country: Canada
facility: Spectrum Health
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: