Clinical trial NCT04009057: Effectiveness, Safety, Adherence, and Health-related Quality of Life in HIV-1 Infected Adults Receiving Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF)
Official title: Multi-center, Israeli, 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
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 143
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 antiretroviral therapy (ART)-naïve and ART-experienced HIV-1 infected adults aged ≥ 18 years initiating treatment with B/F/TAF in routine clinical care in Israel.

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

Exclusion Criteria:

* Participation in any interventional clinical trial

Primary outcomes:
measure: Percentage 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: Percentage 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: Percentage 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: Change in CD4 Cell Count at 3 Months After Initiating or Switching to B/F/TAF
timeFrame: 3 Months
measure: Change in CD4 Cell Count at 6 Months After Initiating or Switching to B/F/TAF
timeFrame: 6 Months
measure: Change in CD4 Cell Count at 12 Months After Initiating or Switching to B/F/TAF
timeFrame: 12 Months
measure: Change in CD4 Cell Count at 24 Months After Initiating or Switching to B/F/TAF
timeFrame: 24 Months
measure: CD4/CD8 Ratio at 3 Months After Initiating or Switching to B/F/TAF
timeFrame: 3 Months
measure: CD4/CD8 Ratio at 6 Months After Initiating or Switching to B/F/TAF
timeFrame: 6 Months
measure: CD4/CD8 Ratio at 12 Months After Initiating or Switching to B/F/TAF
timeFrame: 12 Months
measure: CD4/CD8 Ratio at 24 Months After Initiating or Switching to B/F/TAF
timeFrame: 24 Months
measure: Percentage of Participants Experiencing Adverse Events and Serious Adverse Events
timeFrame: 24 Months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraski Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: