NCT04009057

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

July 9, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

2.7 years

First QC Date

July 2, 2019

Last Update Submit

April 29, 2022

Conditions

HIV-1-infection

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 12 Months after Initiating or Switching to B/F/TAF

    12 Months

Secondary Outcomes (12)

  • Percentage of Participants with HIV-1 RNA Suppression (HIV RNA < 50 copies/mL) at 3 Months After Initiating or Switching to B/F/TAF

    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

    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

    24 Months

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

    3 Months

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

    6 Months

  • +7 more secondary outcomes

Study Arms (1)

B/F/TAF

HIV-1 infected adults who initiate B/F/TAF therapy

Other: B/F/TAF

Interventions

B/F/TAFOTHER

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

Also known as: Biktarvy®
B/F/TAF

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • HIV-1 infection
  • Signed informed consent
  • Initiating treatment with B/F/TAF

You may not qualify if:

  • Participation in any interventional clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rambam Medical Center

Haifa, 3109601, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel Aviv Souraski Medical Center

Tel Aviv, 6423906, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related Publications (1)

  • Antinori A, Yokomaku Y, Elinav H, Pullukcu H, de Wet J, Antela A, Lu PL, Sabranski M, Kim YS, Bonnet F, den Hollander J, Jackson A, Choy CY, Cai W, Zhang F, Thorpe D, Marongiu A, Harrison R, Jarrett J, Boffito M. Quality of Life and Treatment Satisfaction in People with HIV Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Pooled Analysis from Observational Cohort Studies. Infect Dis Ther. 2026 Jan;15(1):217-244. doi: 10.1007/s40121-025-01252-w. Epub 2025 Nov 24.

    PMID: 41284214DERIVED

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

July 9, 2019

Primary Completion

March 21, 2022

Study Completion

March 21, 2022

Last Updated

May 3, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(5)