HIV-1-infectionPhase 4NCT05147740
Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age
A Phase 4 study testing B/F/TAF in people with HIV-1-infection, run by Tulika Singh, MD at 1 site in United States.
Trial summary
To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- B/F/TAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Be at least 65 years of age at the time of signing the informed consent form.
- Be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit.
- Have documented plasma HIV-1 RNA < 50 copies/mL for a minimum of 3 months on current ART regimen.
- Have a plasma HIV-1 RNA < 50 copies/mL at screening visit.
Who cannot join
- Have resistance to tenofovir (K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions), primary INSTI-resistance, or a history of failure on an INSTI-based regimen.
- Have been treated with B/F/TAF
- Participants with CrCl <30 mL/min
- Known or suspected severe hepatic impairment (Child-Pugh Class C)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
DAP Health
Palm Springs, California, 92262
Greg Jackson, BS, MBA, 760-992-0445, gjackson@daphealth.org
Karina Ramirez, 760-656-8450, kramirez@daphealth.org
About this study
Official title: Switching to a Fixed Dose Combination of Biktarvy in Treatment Experienced People With HIV Who Are Currently Virologically Suppressed and at Least 65 Years of Age
To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.
- Conditions
- HIV-1-infection
- Being tested
- B/F/TAF
- Keywords
- HIV, QOL, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B/F/TAFDrug
Also called Biktarvy®
50/200/25 mg fixed-dose combination administered orally once daily without regard to food.
| Study group | Role | What they receive |
|---|---|---|
| B/F/TAF | Experimental | B/F/TAF for 48 weeks Receives: Drug: B/F/TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey.
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. The range of scores is between -33 and +33. The higher the score, the greater the improvement in satisfaction. Satisfaction may be positive or negative.
Measured: 48 weeks
Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey.
Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. The range of scores is between -9 to +3. The higher the score the greater the impact. Impacts may be positive or negative.
Measured: 48 weeks
Secondary outcomes (4)
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24 using FDA snapshot analysis, which defined a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation.
Measured: Week 24
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study (Week 48) using FDA snapshot analysis, which defined a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation.
Measured: Week 48
Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48)
An Adverse Event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related . An AE can be any unfavorable and unintended sign, symptom, or disease associated with the use of a study intervention.
Measured: Week 48
Percentage of patients who reduced their number of total medications from baseline.
Percentage of patients who reduced their number of total medications from baseline. Polypharmacy is defined as 5 or more prescription medications and the Beers Criteria is utilized as a tool to evaluate potentially inappropriate prescriptions in this population.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulika Singh, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Tulika Singh, MD, Desert AIDS Project
- Investigators
- Tulika Singh, MD, Principal investigator, Dap Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147740
- Sponsor's protocol ID
- CO-US-38-5713
- Status last verified
- Dec 2021
- First submitted
- 24 Aug 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching to a Fixed Dose Combination of Biktarvy in Treatment Experienced People With HIV Who Are Currently Virologically Suppressed and at Least 65 Years of Age
- ClinicalTrials.gov ID
- NCT05147740
- Acronym / sponsor ID
- CO-US-38-5713
- Conditions
- HIV-1-infection
- Keywords
- HIV, QOL, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tulika Singh, MDUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B/F/TAF | Experimental | Drug: B/F/TAFB/F/TAF for 48 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Be at least 65 years of age at the time of signing the informed consent form.
- Be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit.
- Have documented plasma HIV-1 RNA < 50 copies/mL for a minimum of 3 months on current ART regimen.
- Have a plasma HIV-1 RNA < 50 copies/mL at screening visit.
Key exclusion criteria (4 listed)
- Have resistance to tenofovir (K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions), primary INSTI-resistance, or a history of failure on an INSTI-based regimen.
- Have been treated with B/F/TAF
- Participants with CrCl <30 mL/min
- Known or suspected severe hepatic impairment (Child-Pugh Class C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B/F/TAFAlso: Biktarvy®50/200/25 mg fixed-dose combination administered orally once daily without regard to food. | Drug | B/F/TAF |
Primary outcome
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey.
Time frame: 48 weeks
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. The range of scores is between -33 and +33. The higher the score, the greater the improvement in satisfaction. Satisfaction may be positive or negative.
Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey.
Time frame: 48 weeks
Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey. The range of scores is between -9 to +3. The higher the score the greater the impact. Impacts may be positive or negative.
4 secondary outcomes
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24
Time frame: Week 24
Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study
Time frame: Week 48
Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48)
Time frame: Week 48
Percentage of patients who reduced their number of total medications from baseline.
Time frame: Week 48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tulika Singh, MD principal investigator
Dap Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing B/F/TAF in people with HIV-1-infection, run by Tulika Singh, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Greg Jackson, BS, MBA (760-992-0445, gjackson@daphealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey. (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.