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RecruitingPhase 2

Incretin Microdosing for Cardiometabolic Health in People With HIV

Incretin Microdosing for Cardiometabolic Health in People With HIV: The REINFORCE Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Secondary Objectives * To evaluate the tolerability of semaglutide microdosing in adults with HIV. * To evaluate changes in weight, waist circumference (WC) and body mass index (BMI) over 12 weeks (W) of semaglutide weight loss induction and 48 W of semaglutide microdosing therapy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

The objectives of this study are as follows: Primary Objective * To determine the rate of weight regain in people living with human immunodeficiency virus (HIV) (PWH) receiving semaglutide microdosing vs. no additional drug following induction therapy. Secondary Objectives * To evaluate the tolerability of semaglutide microdosing in adults with HIV. * To evaluate changes in weight, waist circumference (WC) and body mass index (BMI) over 12 weeks (W) of semaglutide weight loss induction and 48 W of semaglutide microdosing therapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: * Confirmed human immunodeficiency virus type 1 (HIV-1) * On antiretroviral therapy (ART) for greater than or equal to 24 weeks prior to entry and no change in regimen in the 12 weeks prior to entry or planned change for the study duration * HIV-1 ribonucleic acid (RNA) \<200 copies/mL at screening * BMI greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 if also with greater than or equal to 1 weight-related comorbidity * If taking anti-inflammatory or blood-pressure-/lipid-/glucose-lowering medications, no change in dose for greater than or equal to 12 weeks prior to entry and no plans to dose escalate for the study duration * All participants must be willing and able to provide written informed consent and undergo all required study procedures Exclusion Criteria: * Weight greater than or equal to 400 pounds \[due to dual X-ray absorptiometry (DXA) machine limitations\] or unexplained weight change greater than or equal to 5% in the 12 weeks prior to entry * Diagnosis of or on treatment for diabetes mellitus (stable metformin dosing for pre-diabetes not excluded) * Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period * Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period * Active eating disorder * Use of human growth hormone, tesamorelin or anabolic steroids \<12 weeks prior to entry, unless on a stable dose for \>24 weeks prior to entry, or plans to start any of these medications while on study * Active, severe delayed gastric emptying * Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study * Known retinopathy * Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 * Untreated, poorly controlled or previously undiagnosed thyroid disease * Chronic pancreatitis * Known allergy/sensitivity to Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) * Poorly controlled or previously undiagnosed thyroid disease, defined as thyroid-stimulating hormone (TSH) \<0.5 or \>10 milli-international units per liter (mIU/L) at screening * Active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements * Pregnancy, nursing or plans for either during the study period * Use of planned use of any immunomodulatory therapy HIV vaccine, investigational therapy or tumor necrosis factor (TNF-α) therapy during the study period * Current serious illness requiring systemic treatment and/or hospitalization, in the opinion of site investigator

Study sites (1)

TX