Human Immunodeficiency VirusPhase 4SymITANCT04240210
Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)
A Phase 4 study testing Symtuza in people with Human Immunodeficiency Virus, run by Midland Research Group, Inc. at 1 site in United States.
Trial summary
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COB/FTC/TAF) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability3. These traits have the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Symtuza
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2019to 1 Dec 2021
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age.
- HIV positive receiving ART of any type.
- Currently on an integrase containing regimen AND Reports non-adherent due to medication intolerance.
- GFR≥30mL/min.
- AST/ALT ≤ 3 times upper limit of normal. (AST- U/L 10-40), (ALT- U/L 9-46)
- Total bilirubin of ≤1.5 mg/dL.
Who cannot join
- Known resistance to darunavir or tenofovir
- Known intolerance to Symtuza or its components
- Current pregnancy
- Requires continued use of any of the agents in table 6.2.3.2.4
- Cirrhosis, regardless of compensation status
- Active, serious infections within 30 days of baseline
Show all 9Show fewer
- History of malignancy within 5 years of baseline, except cutaneous Kaposi's sarcoma, basal cell or resected non-invasive cutaneous squamous cell carcinoma
- Life expectancy of less than a year
- Participation in any other investigation study 30 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Midland Research Group, Inc
Oakland Park, Florida, 33334
About this study
Official title: SymITA: Switch to DRV/COB/FTC/TAF From Integrase Containing Regimens to Evaluate Changes in Tolerability/Adherence
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COB/FTC/TAF) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability3. These traits have the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. We propose a two part study design to evaluate if patients who have suboptimal adherence due to integrase inhibitor intolerance may better tolerate Symtuza and subsequently have improved adherence.
Read the detailed description
With the advent of anti-retroviral therapy, HIV transformed into a manageable chronic disease for patients who were able to obtain medications, provided they could remain adherent to them. When single tablet regimens (STR) became available, adherence to HIV medications was made easier for many patients. However even years after STR became available, 38% of patients reported they do not maintain optimal adherence to their HIV medications. While there are many factors that contribute to this problem, medication intolerance contributes to suboptimal adherence for many patients
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability. This trait has the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. We are not aware of any studies that have examined this potential and find that information gap worth investigating.
We propose a two part study design to evaluate if patients who have suboptimal adherence due to integrase inhibitor intolerance may have better tolerability to Symtuza and subsequently have improved adherence.
The initial portion of the study will consist of a self-administered adherence survey offered over a 4 month period to established patients at Midland Medical Center who are HIV+, regardless of disease state or regimen. Subjects who self-identify as non-adherent due to tolerability issues will be screened for enrollment in the primary study. Subjects found to be non-adherent due to other issues will be referred back to their provider.
Subjects who are referred for screening who are on an integrase inhibitor and who do not have a contraindication will be enrolled, will complete a Patient Reported Outcome survey (PRO) to assess side effects/quality of life, and switched to Symtuza. Subjects who are not enrolled in the study will be referred back to their provider to address the issues with tolerance and adherence.
Subjects will be followed for 4 months. During that period, they will be brought back for evaluation at the end of the first month and the end of the fourth month. At those evaluations, they will again complete the PRO and adherence surveys to assess tolerability and adherence. At the evaluations, they will also be monitored for safety and effectiveness via physical exams and laboratory studies (Complete Blood Count, Complete Metabolic Panel, Urinalysis, CD4 panel, HIV1 Quantitative viral load).
The de-identified laboratory and survey results from the baseline and subsequent assessments will be turned over to a statistician to evaluate changes in adherence, tolerability, effectiveness, and safety.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Symtuza
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymtuzaDrug
The study is a prospective cohort analysis of change in adherence, tolerability and safety of subjects who reports poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens when they are switched to DRV/COB/FTC/TAF and monitored for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| To assess degree of adherence to ART in a real world seeting. | No intervention | Part I of the study is a Cohort Survey of HIV+ outpatient clinic patients currently receiving ART to assess medication adherence and tolerability by determining a change in adherence and tolerability from baseline to 4 months, measured by standardized patient reported outcome and adherence surveys |
| Potential changes in ART adherence when switced to Symtuza. | Experimental | Part 2 of the study is a prospective cohort analysis of change in adherence, tolerability and safety of subjects who reports poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens when they are switched to DRV/COB/FTC/TAF and monitored for 4 months. Receives: Drug: Symtuza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 of the study is a cohort survey of change in adherence, tolerability and safety of subjects who report poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens.
To evaluate trends and patterns in subjects who report sub-optimal adherence, analyzed by intention to treat with Integrase Inhibitor based Antiretroviral containing regimens, based upon the subjects completion of the Midland ART Adherence Survey (MAAS)
Measured: 4 months
Secondary outcomes (4)
To determine potential changes in ART adherence in subjects who report sub-optimal adherence due to side effects from integrase containing regimens after switching to Symtuza.
Sub-optimal adherence will be determined by comparing the study subjects completed Midland ART Adherence Survey at the week 4 visit to the week 16 visit to the number of the investigational product (Symtuza) tablets that are counted at week 4 visit and week 16 visit.
Each dispensed bottle of IP (Symtuza) will contain 30 tablets.
Measured: 4 months
To evaluate the tolerability of switching from an integrase inhibitor containing regimen to Symtuza.
We will be using the standardized Patient Reported Outcomes (PRO) questionnaire to determine a percentage of subjects who report suboptimal adherence due to tolerance issues/side effects and those who report suboptimal adherence due to reasons other than tolerance issues/side effects.
Measured: 4 months
Safety and efficacy of switching from integrase inhibitor containing regimen to Symtuza as determined by the proportion of subjects with virologic failure, a change in laboratory parameters and change in CD4 cell count from baseline.
- We will be looking at the proportion of subjects that have an HIV-1 RNA ≥ 50 copies/mL at baseline and at week 16 and comparing them to the subjects level of ART adherence.
- There will be an assessment of whether or not there are any significant laboratory changes in subjects serum Creatinine- (0.70-1.33 mg/dL) , AST- (10-35 u/L) and ALT-(9-46 u/L) when compared to week 16 from the baseline evaluation.
- We will compare any laboratory changes in the subjects Absolute CD4+ cell count- (490-1740 cells/uL) along with the % of CD4 cells- (30-61%) from the subjects week 16 laboratory levels to the baseline assessment by using the study site determined laboratory.
Measured: 4 months
To evaluate for potential weight loss when switching from integrase inhibitor containing regimen to Symtuza.
There will be an assessment of the subjects weight in kilograms- (kg) from the initial baseline visit to the week 16 visit with recorded BMI.
Initial subjects Body Mass Index (BMI) will be assessed by using the formula: weight (kg) / [height (m)]2
The World Health Organization's (WHO) recommended body weight based on BMI values for adults will be referenced.
Category BMI range - kg/m2 Severe Thinness < 16 Moderate Thinness 16 - 17 Mild Thinness 17 - 18.5 Normal 18.5 - 25 Overweight 25 - 30 Obese Class I 30 - 35 Obese Class II 35 - 40 Obese Class III > 40
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start17 Sep 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Why it stopped: Lack of eligible enrollees/ Halted by Primary Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midland Research Group, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Anthony Ciesielski, MD, Principal investigator, Midland Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240210
- Sponsor's protocol ID
- TMC114FD2HTX4005
- Acronym
- SymITA
- Status last verified
- Sep 2024
- First submitted
- 6 Jan 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ortego C, Huedo-Medina TB, Llorca J, Sevilla L, Santos P, Rodriguez E, Warren MR, Vejo J. Adherence to highly active antiretroviral therapy (HAART): a meta-analysis. AIDS Behav. 2011 Oct;15(7):1381-96. doi: 10.1007/s10461-011-9942-x.
PubMed 21468660Robbins RN, Spector AY, Mellins CA, Remien RH. Optimizing ART adherence: update for HIV treatment and prevention. Curr HIV/AIDS Rep. 2014 Dec;11(4):423-33. doi: 10.1007/s11904-014-0229-5.
PubMed 25304006Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018 Jan;5(1):e23-e34. doi: 10.1016/S2352-3018(17)30179-0. Epub 2017 Oct 6.
PubMed 28993180
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SymITA: Switch to DRV/COB/FTC/TAF From Integrase Containing Regimens to Evaluate Changes in Tolerability/Adherence
- ClinicalTrials.gov ID
- NCT04240210
- Acronym / sponsor ID
- SymITA / TMC114FD2HTX4005
- Conditions
- Human Immunodeficiency Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of eligible enrollees/ Halted by Primary Sponsor
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Midland Research Group, Inc.University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 27 Jan 2020 (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.
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COB/FTC/TAF) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability3. These traits have the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. We propose a two part study design to evaluate if patients who have suboptimal adherence due to integrase inhibitor intolerance may better tolerate Symtuza and subsequently have improved adherence.
Detailed description
With the advent of anti-retroviral therapy, HIV transformed into a manageable chronic disease for patients who were able to obtain medications, provided they could remain adherent to them. When single tablet regimens (STR) became available, adherence to HIV medications was made easier for many patients. However even years after STR became available, 38% of patients reported they do not maintain optimal adherence to their HIV medications. While there are many factors that contribute to this problem, medication intolerance contributes to suboptimal adherence for many patients
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability. This trait has the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. We are not aware of any studies that have examined this potential and find that information gap worth investigating.
We propose a two part study design to evaluate if patients who have suboptimal adherence due to integrase inhibitor intolerance may have better tolerability to Symtuza and subsequently have improved adherence.
The initial portion of the study will consist of a self-administered adherence survey offered over a 4 month period to established patients at Midland Medical Center who are HIV+, regardless of disease state or regimen. Subjects who self-identify as non-adherent due to tolerability issues will be screened for enrollment in the primary study. Subjects found to be non-adherent due to other issues will be referred back to their provider.
Subjects who are referred for screening who are on an integrase inhibitor and who do not have a contraindication will be enrolled, will complete a Patient Reported Outcome survey (PRO) to assess side effects/quality of life, and switched to Symtuza. Subjects who are not enrolled in the study will be referred back to their provider to address the issues with tolerance and adherence.
Subjects will be followed for 4 months. During that period, they will be brought back for evaluation at the end of the first month and the end of the fourth month. At those evaluations, they will again complete the PRO and adherence surveys to assess tolerability and adherence. At the evaluations, they will also be monitored for safety and effectiveness via physical exams and laboratory studies (Complete Blood Count, Complete Metabolic Panel, Urinalysis, CD4 panel, HIV1 Quantitative viral load).
The de-identified laboratory and survey results from the baseline and subsequent assessments will be turned over to a statistician to evaluate changes in adherence, tolerability, effectiveness, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| To assess degree of adherence to ART in a real world seeting. | No intervention | –Part I of the study is a Cohort Survey of HIV+ outpatient clinic patients currently receiving ART to assess medication adherence and tolerability by determining a change in adherence and tolerability from baseline to 4 months, measured by standardized patient reported outcome and adherence surveys |
| Potential changes in ART adherence when switced to Symtuza. | Experimental | Drug: SymtuzaPart 2 of the study is a prospective cohort analysis of change in adherence, tolerability and safety of subjects who reports poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens when they are switched to DRV/COB/FTC/TAF and monitored for 4 months. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age.
- HIV positive receiving ART of any type.
- Currently on an integrase containing regimen AND Reports non-adherent due to medication intolerance.
- GFR≥30mL/min.
- AST/ALT ≤ 3 times upper limit of normal. (AST- U/L 10-40), (ALT- U/L 9-46)
Key exclusion criteria (9 listed)
- Known resistance to darunavir or tenofovir
- Known intolerance to Symtuza or its components
- Current pregnancy
- Requires continued use of any of the agents in table 6.2.3.2.4
- Cirrhosis, regardless of compensation status
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 |
|---|---|---|
| SymtuzaThe study is a prospective cohort analysis of change in adherence, tolerability and safety of subjects who reports poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens when they are switched to DRV/COB/FTC/TAF and monitored for 4 months. | Drug | Potential changes in ART adherence when switced to Symtuza. |
Primary outcome
Part 1 of the study is a cohort survey of change in adherence, tolerability and safety of subjects who report poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens.
Time frame: 4 months
To evaluate trends and patterns in subjects who report sub-optimal adherence, analyzed by intention to treat with Integrase Inhibitor based Antiretroviral containing regimens, based upon the subjects completion of the Midland ART Adherence Survey (MAAS)
4 secondary outcomes
To determine potential changes in ART adherence in subjects who report sub-optimal adherence due to side effects from integrase containing regimens after switching to Symtuza.
Time frame: 4 months
To evaluate the tolerability of switching from an integrase inhibitor containing regimen to Symtuza.
Time frame: 4 months
Safety and efficacy of switching from integrase inhibitor containing regimen to Symtuza as determined by the proportion of subjects with virologic failure, a change in laboratory parameters and change in CD4 cell count from baseline.
Time frame: 4 months
To evaluate for potential weight loss when switching from integrase inhibitor containing regimen to Symtuza.
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Lack of eligible enrollees/ Halted by Primary Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 21468660Ortego C, Huedo-Medina TB, Llorca J, Sevilla L, Santos P, Rodriguez E, Warren MR, Vejo J. Adherence to highly active antiretroviral therapy (HAART): a meta-analysis. AIDS Behav. 2011 Oct;15(7):1381-96. doi: 10.1007/s10461-011-9942-x.
- Background: PubMed 25304006Robbins RN, Spector AY, Mellins CA, Remien RH. Optimizing ART adherence: update for HIV treatment and prevention. Curr HIV/AIDS Rep. 2014 Dec;11(4):423-33. doi: 10.1007/s11904-014-0229-5.
- Background: PubMed 28993180Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018 Jan;5(1):e23-e34. doi: 10.1016/S2352-3018(17)30179-0. Epub 2017 Oct 6.
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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.
Anthony Ciesielski, MD principal investigator
Midland Research Group
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 Symtuza in people with Human Immunodeficiency Virus, run by Midland Research Group, Inc. 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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?
The study was stopped early (reason given: Lack of eligible enrollees/ Halted by Primary Sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 of the study is a cohort survey of change in adherence, tolerability and safety of subjects who report poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240210, which also lists 3 linked publications.
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 19 Sep 2024.