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

Gilead Sciences143 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

143

Conditions

HIV-1-infection

Interventions

B/F/TAFOTHER

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 Exclusion Criteria: * Participation in any interventional clinical trial

Locations (5)

Rambam Medical Center

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Kaplan Medical Center

Rehovot, Israel

Tel Aviv Souraski Medical Center

Tel Aviv, Israel

Sheba Medical Center

Outcomes

Primary Outcomes

Percentage 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

Percentage 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

Percentage 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

Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF

Time frame: 3 Months

Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF

Time frame: 6 Months

Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF

Time frame: 12 Months

Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF

Time frame: 24 Months

CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF

Time frame: 3 Months

CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF

Data from ClinicalTrials.gov

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