Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide

Gilead Sciences201 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

201

Conditions

HIV-1-infection

Interventions

B/F/TAFDRUG

B/F/TAF administered in accordance with the approved product monograph

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Clinique Medicale du Quartier Latin

Montreal, Canada

University of Ottawa

Ottawa, Canada

Regina General Hospital

Regina, Canada

St. Clair Medical Association/Balmoral Clinic

Toronto, Canada

Outcomes

Primary Outcomes

Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after initiating or switching to B/F/TAF

Time frame: 12 months

Secondary Outcomes

Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months after initiating or switching to B/F/TAF

Time frame: 3 months

Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 6 Months after initiating or switching to B/F/TAF

Time frame: 6 months

Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 24 Months after initiating or switching to B/F/TAF

Time frame: 24 months

Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 36 Months after initiating or switching to B/F/TAF

Time frame: 36 months

Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 48 Months after initiating or switching to B/F/TAF

Time frame: 48 months

Proportion of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 60 Months after initiating or switching to B/F/TAF

Time frame: 60 months

Change in CD4 Cell Count at 3 Months

Time frame: 3 months

Change in CD4 Cell Count at 6 Months

Time frame: 6 months

Change in CD4 Cell Count at 12 Months

Data from ClinicalTrials.gov

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