HIV InfectionsHEALTH-COGNCT06013579
Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV
A study testing Phase 1 Gym Exercise HIIT, Phase 1 Gym Exercise CME and Phase 2 Home Exercise Coaching Text Messages in people with HIV Infections and Cognitive Impairment, run by University of Alabama at Birmingham at 3 sites in United States.
Trial summary
People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and although physical activity is a promising target to mitigate such risk, this population engages in low levels of physical activity. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Cognitive Impairment
- What is being tested?
- Phase 1 Gym Exercise HIIT, Phase 1 Gym Exercise CME and Phase 2 Home Exercise Coaching Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2023to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed HIV
- Sedentary lifestyle, defined as self-reported PA that breaks a sweat <3 days/week, with no regular resistance exercise for 3 months preceding study;
- Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue Scale)
- On a current, contemporary ART regimen for >=12 months;
- HIV-1 RNA <200 copies/mL in the past 12 months (assessed via medical records)
- Willing to engage in a supervised exercise program 3 times/week for 4 months
Show all 9Show fewer
- Cell phone or email to accept messages
- Weight <450 lbs
- Medical clearance by study healthcare professional
Who cannot join
- Weight over 450 pounds
- Use of sex hormone therapy, if on for ≤3 months (stable doses for >3 months will be permitted)
- Use of other hormone replacement, if on for ≤ 3 months (stable doses >3 months will be permitted)
- Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue,
- Diagnosis of mitochondrial disease,
- Active substance abuse or other factors that could prevent compliance or safety with study visits, at the discretion of the site investigator,
Show all 17Show fewer
- Reasons for medical exclusion, as determined by Nurse Practioner:
- Uncontrolled hypertension defined as resting systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg; participants who do not meet these criteria at first screening will be reevaluated, including follow-up evaluation by their primary care provider with initiation or adjustment of anti-hypertensive medications,
- Unstable ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test without negative follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist,
- New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, uncontrolled angina, or uncontrolled arrhythmia,
- Pulmonary disease requiring the use of supplemental oxygen at rest or with physical exertion,
- Malignancy requiring chemotherapy or radiation therapy within 24 weeks prior to enrollment,
- Poorly controlled diabetes, as evidenced by hemoglobin A1c > 8.5, documented within 6 months of study visit or current use of insulin,
- Surgery/trauma/injury/fracture within 24 weeks prior to enrollment that, in the opinion of the study clinician, may impact a subject's baseline functional testing and ability to exercise,
- Balance impairments that may impact functional testing and ability to safely exercise as reported by the participant or in their medical record,
- Orthopedic problems (e.g., severe osteoarthritis, rheumatoid arthritis) that greatly limit the ability to perform moderate intensity resistance exercise (e.g., unable to be properly positioned in exercise equipment or to have severely restricted range of motion even after modifications have been made),
- Persons who, in the judgment of the study clinician, appear to have unstable health or are incapable of safely participating in the exercise intervention.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Kristine Erlandson, MD, 303-724-4941, kristine.erlandson@ucdenver.edu
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Pariya Wheeler, PhD, 205-996-1210, plfazeli@uab.edu
- Recruiting
University of Washington
Seattle, Washington, 98195
Allison Webel, PhD, 216-650-9227, awebel@uw.edu
About this study
Official title: Examining the Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV (HEALTH-Cog)
People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and although physical activity is a promising target to mitigate such risk, this population engages in low levels of physical activity. Few studies have tested cognitive effects of exercise interventions or examined mechanisms of adherence to long-term exercise among diverse samples of midlife and older people with HIV. The current study will leverage an existing R01 to address these gaps and provide implications for development of personalized approaches for the treatment and prevention of cognitive impairment and dementia in older people with HIV.
Read the detailed description
The population of people with HIV (PWH) is aging, and are at higher risk for Alzheimer's disease and related dementias (ADRD) than seronegative counterparts. Although physical activity (PA) is a promising protective factor to mitigate ADRD risk, few well-powered PA intervention studies have rigorously tested cognitive outcomes among older PWH, a population with rates of moderate to vigorous PA well below recommended guidelines. Further, given that adherence to habitual PA diminishes after supervised interventions, identifying mechanisms of adherence (MoA) to habitual PA among older PWH is germane to develop effective and durable interventions to protect cognitive health. The proposed R01 will leverage the High-Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH), a two-site RCT (University of Washington [UW], University of Colorado Denver [UCD]) of 100 older PWH examining: 1) if 4 months of supervised high-intensity interval training (HIIT) mitigates physical function impairments and fatigue to a greater extent than continuous moderate exercise (CME); 2) the effects of a 3 month text-messaging intervention on PA adherence. In contrast to CME, where aerobic exercise is performed continuously for a specified duration, HIIT, which uses repeated alternating bouts of highintensity and lower intensity aerobic exercise, has shown superior efficacy in improving physiological and cognitive outcomes, and is associated with superior enjoyment which may increase adherence to PA regimens. The proposed R01 (HEALTH-COG) will leverage the two HEALTH sites, add a new racially diverse UAB site, and add new measures (psychological MoA measures, cognitive function assessments, biomarkers) and a few 12 month follow-up to the parent study. We estimate that of our planned sample of N=100, n=50 will be enrolled at UAB and n=50 total at UW and UCD. Our primary aim is to compare the effects of a 4 month supervised HIIT or CME intervention on (1°) cognitive functioning and (2°) subjective cognitive symptoms. Our exploratory aim is to evaluate putative biomarkers underlying the effect of PA on cognition (blood markers: e.g., BDNF, VEGF, IL-6 and neuroimaging markers: cerebral blood flow, resting state functional connectivity, and brain volume). Our secondary aim is to determine MoA to long-term PA maintenance at 12 months. This aim will examine distal predictors of long-term PA, including sociodemographic, clinical, and intervention factors (i.e., changes in parent R01 physical outcomes [cardiorespiratory fitness], condition [HIIT vs CME], [coaching vs control]), as well as proximal psychological MoA assessed in real-time, using EMA (e.g., self-efficacy, perceived benefits, motivation, social support). Testing efficacy and mechanisms of exercise interventions on cognitive outcomes and understanding psychological MoA of habitual PA following supervised interventions will aid in the development and implementation of personalized medicine approaches for the treatment and prevention of cognitive impairment and ADRD in older PWH.
- Conditions
- HIV Infections, Cognitive Impairment
- Being tested
- Phase 1 Gym Exercise HIIT, Phase 1 Gym Exercise CME, Phase 2 Home Exercise Coaching Text Messages, Phase 2 Home Exercise Control Text Messages
- Keywords
- HIV, Cognitive Function, Exercise
- Medical subject headings
- HIV Infections, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 Gym Exercise HIITBehavioural
Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes.
Phase 1 Gym Exercise CMEBehavioural
Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes.
Phase 2 Home Exercise Coaching Text MessagesBehavioural
The coaching intervention will consist of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. One daily message with a survey will be sent, and responses to survey items will determine the subsequent once daily motivational message.Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages will be varied each week so that even if participants continue to report the same barriers they receive different text messages.
Phase 2 Home Exercise Control Text MessagesBehavioural
The control group will receive general daily texts from the study team (i.e., "Hope you are doing well!"), and reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Moderate Exercise (CME) | Active comparator | Following a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes. Receives: Behavioral: Phase 1 Gym Exercise CME; Behavioral: Phase 2 Home Exercise Coaching Text Messages; Behavioral: Phase 2 Home Exercise Control Text Messages |
| High-Intensity Interval Training (HIIT) | Active comparator | Following a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes. Receives: Behavioral: Phase 1 Gym Exercise HIIT; Behavioral: Phase 2 Home Exercise Coaching Text Messages; Behavioral: Phase 2 Home Exercise Control Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
Measured: Baseline visit
Cognition
Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
Measured: 4 month follow-up visit
Cognition
Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
Measured: 7 month follow-up visit
Cognition
Cognitive assessment battery tests speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
Measured: 12 month follow-up visit
Secondary outcomes (1)
Psychological Mechanisms of Adherence
Measures of mechanisms of adherence include self-efficacy, motivation, self-regulation strategies, outcome expectations, affective states, and social cohesion and support via in-person surveys and interviews.
Measured: 12 month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Aug 2023
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of Washington, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Pariya L. Fazeli, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013579
- Sponsor's protocol ID
- 1R01AG077997-01A1
- Other IDs
- 1R01AG077997-01A1
- Acronym
- HEALTH-COG
- Status last verified
- Dec 2025
- First submitted
- 22 Aug 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of High-Intensity Exercise to Attenuate Cognitive Function Limitations and Train Exercise Habits in Older People Living With HIV (HEALTH-Cog)
- ClinicalTrials.gov ID
- NCT06013579
- Acronym / sponsor ID
- HEALTH-COG / 1R01AG077997-01A1
- Conditions
- HIV Infections, Cognitive Impairment
- Keywords
- HIV, Cognitive Function, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of Washington, National Institute on Aging (NIA)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Aug 2023 (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.
People aging with HIV are at higher risk for Alzheimer's disease and related dementias, and although physical activity is a promising target to mitigate such risk, this population engages in low levels of physical activity. Few studies have tested cognitive effects of exercise interventions or examined mechanisms of adherence to long-term exercise among diverse samples of midlife and older people with HIV. The current study will leverage an existing R01 to address these gaps and provide implications for development of personalized approaches for the treatment and prevention of cognitive impairment and dementia in older people with HIV.
Detailed description
The population of people with HIV (PWH) is aging, and are at higher risk for Alzheimer's disease and related dementias (ADRD) than seronegative counterparts. Although physical activity (PA) is a promising protective factor to mitigate ADRD risk, few well-powered PA intervention studies have rigorously tested cognitive outcomes among older PWH, a population with rates of moderate to vigorous PA well below recommended guidelines. Further, given that adherence to habitual PA diminishes after supervised interventions, identifying mechanisms of adherence (MoA) to habitual PA among older PWH is germane to develop effective and durable interventions to protect cognitive health. The proposed R01 will leverage the High-Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH), a two-site RCT (University of Washington [UW], University of Colorado Denver [UCD]) of 100 older PWH examining: 1) if 4 months of supervised high-intensity interval training (HIIT) mitigates physical function impairments and fatigue to a greater extent than continuous moderate exercise (CME); 2) the effects of a 3 month text-messaging intervention on PA adherence. In contrast to CME, where aerobic exercise is performed continuously for a specified duration, HIIT, which uses repeated alternating bouts of highintensity and lower intensity aerobic exercise, has shown superior efficacy in improving physiological and cognitive outcomes, and is associated with superior enjoyment which may increase adherence to PA regimens. The proposed R01 (HEALTH-COG) will leverage the two HEALTH sites, add a new racially diverse UAB site, and add new measures (psychological MoA measures, cognitive function assessments, biomarkers) and a few 12 month follow-up to the parent study. We estimate that of our planned sample of N=100, n=50 will be enrolled at UAB and n=50 total at UW and UCD. Our primary aim is to compare the effects of a 4 month supervised HIIT or CME intervention on (1°) cognitive functioning and (2°) subjective cognitive symptoms. Our exploratory aim is to evaluate putative biomarkers underlying the effect of PA on cognition (blood markers: e.g., BDNF, VEGF, IL-6 and neuroimaging markers: cerebral blood flow, resting state functional connectivity, and brain volume). Our secondary aim is to determine MoA to long-term PA maintenance at 12 months. This aim will examine distal predictors of long-term PA, including sociodemographic, clinical, and intervention factors (i.e., changes in parent R01 physical outcomes [cardiorespiratory fitness], condition [HIIT vs CME], [coaching vs control]), as well as proximal psychological MoA assessed in real-time, using EMA (e.g., self-efficacy, perceived benefits, motivation, social support). Testing efficacy and mechanisms of exercise interventions on cognitive outcomes and understanding psychological MoA of habitual PA following supervised interventions will aid in the development and implementation of personalized medicine approaches for the treatment and prevention of cognitive impairment and ADRD in older PWH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Moderate Exercise (CME) | Active comparator | Behavioral: Phase 1 Gym Exercise CME, Behavioral: Phase 2 Home Exercise Coaching Text Messages, Behavioral: Phase 2 Home Exercise Control Text MessagesFollowing a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes. |
| High-Intensity Interval Training (HIIT) | Active comparator | Behavioral: Phase 1 Gym Exercise HIIT, Behavioral: Phase 2 Home Exercise Coaching Text Messages, Behavioral: Phase 2 Home Exercise Control Text MessagesFollowing a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed HIV
- Sedentary lifestyle, defined as self-reported PA that breaks a sweat <3 days/week, with no regular resistance exercise for 3 months preceding study;
- Fatigued (≥2.0 on either of the first two screening items on the HIV-Related Fatigue Scale)
- On a current, contemporary ART regimen for >=12 months;
- HIV-1 RNA <200 copies/mL in the past 12 months (assessed via medical records)
Key exclusion criteria (17 listed)
- Weight over 450 pounds
- Use of sex hormone therapy, if on for ≤3 months (stable doses for >3 months will be permitted)
- Use of other hormone replacement, if on for ≤ 3 months (stable doses >3 months will be permitted)
- Anemia (Hemoglobin ≤9 g/dL for women or ≤10 g/dL for men) due to contribution to fatigue,
- Diagnosis of mitochondrial disease,
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 |
|---|---|---|
| Phase 1 Gym Exercise HIITFollowing a 5-minute warm-up at 50% VO2peak, high and moderate-intensity exercise bouts alternate, progressing to five bouts of 4-minute high-intensity exercise (90% VO2peak), alternating with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8, followed by a 5 minute cool-down. The total exercise time is 42 minutes. | Behavioural | High-Intensity Interval Training (HIIT) |
| Phase 1 Gym Exercise CMEFollowing a 4 minute warm-up at 50% VO2peak, the participant walks for up to 42 continuous minutes at 60% VO2peak172, followed by a 4 minute cool-down. The total exercise time is 50 minutes. | Behavioural | Continuous Moderate Exercise (CME) |
| Phase 2 Home Exercise Coaching Text MessagesThe coaching intervention will consist of daily text messages tailored to the individual participant's self-reported symptom experiences and barriers to exercise on that specific day. One daily message with a survey will be sent, and responses to survey items will determine the subsequent once daily motivational message.Tailored messages address a range of possible barriers to adherence based on past research, and will provide advice and guidance. Text messages will be varied each week so that even if participants continue to report the same barriers they receive different text messages. | Behavioural | Continuous Moderate Exercise (CME), High-Intensity Interval Training (HIIT) |
| Phase 2 Home Exercise Control Text MessagesThe control group will receive general daily texts from the study team (i.e., "Hope you are doing well!"), and reminding them of their next study appointments. These text messages are primarily social/generic in content and serve to maintain involvement and enhance retention of the control group. | Behavioural | Continuous Moderate Exercise (CME), High-Intensity Interval Training (HIIT) |
Primary outcome
Cognition
Time frame: Baseline visit
Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
Cognition
Time frame: 4 month follow-up visit
Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
Cognition
Time frame: 7 month follow-up visit
Cognitive assessment battery test speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
Cognition
Time frame: 12 month follow-up visit
Cognitive assessment battery tests speed of processing, learning, memory, executive functioning, verbal fluency, working memory, motor, subjective cognitive complaints, and everyday functioning.
1 secondary outcome
Psychological Mechanisms of Adherence
Time frame: 12 month follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1 Gym Exercise HIIT, Phase 1 Gym Exercise CME and Phase 2 Home Exercise Coaching Text Messages in people with HIV Infections and Cognitive Impairment, run by University of Alabama at Birmingham at 3 sites 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 9 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pariya Wheeler, PhD (205-996-0330, plfazeli@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: Baseline visit). The study lists 4 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 8 Dec 2025.