An interventional study of Exercise in HIV/AIDS, Dysglycemia and Alcohol Use Disorder, sponsored by Louisiana State University Health Sciences Center in New Orleans. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Not applicable, Interventional, and Prevention
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Among 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States — 111 open to participants now, 153 under way, 9 of them phase 3. Acquired Immunodeficiency Syndrome · United States.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, this one is the 611th largest by enrollment of the 1,290 interventional ones that give a count, is one of 56 that started in 2017, is one of 642 with no phase, and was the 1,211th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →111 of the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States are open now. Recruiting first, the newest first:
Nicky Mehtani, MD, MPH · Sites in United States
Ages 25–64
Columbia University · Sites in United States
Ages 18+ · Healthy volunteers
BioNTech SE · Sites in United States, South Africa
Ages 18–50 · Healthy volunteers
CAN Community Health · Sites in United States
Ages 18+
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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1,670 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 384 · Phase 2 258 · Phase 3 156 · Phase 4 81
First in 1981; this study’s year is marked. 56 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 68 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 60 across the 1,290 interventional studies, 154 across the 195 observational. Of the 1,449 that completed or were terminated, 355 (24%) have results posted.
This tab as a report to print or save as PDF → With an account.
510 of 1,670 have an industry lead sponsor. The 10 most frequent:
Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 72 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Louisiana State University Health Sciences Center in New Orleans has 3 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
56 of the studies in Acquired Immunodeficiency Syndrome with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT04958122Phase 3University of Southern CaliforniaCefixime Clinical Trial | 2027-01-01 |
| NCT07044297Phase 3Merck Sharp & Dohme LLCA Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | 2027-07-22 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT05159466Tulane UniversityTulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors | 2026-11 |
Add all 56 to your calendar (.ics) → With an account.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Cross-sectional and prospective studies are proposed to test the prediction that a higher proportion of HIV+ individuals with hazardous alcohol drinking with subclinical fasting dysglycemia will present with impaired oral glucose tolerance and dysfunctional metabolic skeletal muscle phenotype. Prospective studies will test the efficacy of an exercise intervention in improving glycemic control. Results will inform larger scale interventions to ameliorate metabolic comorbidities, improve health, quality of life, and possibly decrease hazardous alcohol drinking.
Adult male and female in care PLWHA with fasting plasma glucose (FPG) >94 mg/dL and \<125 mg/dL will be recruited. Measures of FPG and HbA1c obtained from overnight fasted subjects. Alcohol use disorder (AUD) will be assessed by AUDIT and time-line follow back questionnaires, coupled with Phosphatidylethanol (PEth) measures. Glucose tolerance will be assessed by oral glucose tolerance test (OGTT). Blood sample collected at the time of the OGTT will be used for determination of circulating levels of adipokines (adiponectin and resistin).
A subset of adult male and female PLWHA +/- AUD with impaired OGTT will be recruited to undergo skeletal muscle (SKM) biopsy (vastus lateralis), 90 min after a defined (calorie and nutrient composition) meal (i.e.,Ensure, Carnation Instant Breakfast). Muscle samples will be used for phenotype characterization (markers of inflammation, insulin signaling, mitochondrial homeostasis) and for myoblast isolation.
Adult male and female PLWHA +/- AUD with impaired OGTT will undergo a moderate intensity aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit Zip) to monitor daily activity and steps. A SKM biopsy will be performed after completion of the exercise protocol in a subset of subjects to examine the changes in gene expression and myoblast mitochondrial oxidative capacity. We will expand recruitment by enrolling PLWHA +/- AUD based on a FPG between 94-120 mg/dL to participate in the exercise intervention. Clearance for participation in this study will require EKG, completion of a physical activity readiness questionnaire, and medical clearance from a staff clinician. Individuals with significant peripheral neuropathies or the prevalence of significant cardiovascular impairments (i.e. resting cardiac abnormalities or arrhythmias, severe hypertension, etc.) will be excluded from exercise testing or intervention. The 10-week exercise intervention program will consist of aerobic exercise 3 days per week of moderate intensity for 30-45 minutes each session with the goal of achieving 135 minutes per week. The program will begin at low-moderate intensity (40 to 50% of heart rate reserve; HRR) and progress to a higher intensity (50 to 60% HRR) exercise after week 4 of the program. The frequency and duration of exercise sessions will remain constant after week 4 so the absolute dose of exercise will be altered through increasing intensity, i.e. from low-moderate to more vigorous. All exercise will be completed on a treadmill at the Louisiana State University Health Sciences Center (LSUHSC) Wellness Center. Additionally, each participant will be provided with a Fitbit Zip to monitor daily activity and steps. Data from the Fitbit Zip will be downloaded weekly basis. Participants will be given a healthy step goal of 7000 steps per day. Based on initial step counts after the first week of wearing the accelerometer, individual goals will be discussed with the participants. Personal limitations that develop during the study period (i.e. peripheral neuropathy, orthopedic limitation, etc.) will be monitored and will be reason for exclusion from the exercise program. All sessions will be supervised and adherence to the exercise prescription will be fully monitored under the supervision and care of Dr. Stefany Primeaux in consultation with Dr. Neil Johannsen.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aerobic exercise program using treadmill.
Behavioral: Exercise
The exercise intervention consists of moderate intensity aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit Zip) to monitor daily activity and steps. Aerobic exercise will be conducted over 10-weeks in PLWHA +/- AUD. The programs will consist of aerobic exercise 3 days per week of moderate intensity for 30-45 minutes each session with the goal of achieving 135 minutes per week. The program will begin at low-moderate intensity and progress to higher intensity exercise after week 4 of the program. All exercise will be completed on a treadmill and supervised by study staff. Each participant will be provided with a Fitbit Zip to monitor daily activity and steps with a goal of 7000 steps per day.
Fasting plasma glucose and OGTT values (subclinical dysglycemia)
Risk for subclinical dysglycemia
Time frame: Baseline
Skeletal muscle phenotype
Subclinical dysglycemia associated with dysfunctional skeletal muscle measured by myomiRs
Time frame: Baseline
Fasting plasma glucose
Glycemic control measured by fasting plasma glucose
Time frame: Change from baseline in fasting plasma glucose after 10 weeks
myomiRs
Dysfunctional SKM measured by myomiRs
Time frame: Change from baseline in myomiRs after 10 weeks
Plan to share: No — Requests for access to biological samples or existing clinical data obtained from our subjects will be evaluated by Dr. Molina.
Ran from Nov 2017 to primary completion in Sep 2023, 69 months.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 69 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Louisiana State University Health Sciences Center in New Orleans