Semaglutide for Weight Management in People With HIV
(REINFORCE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called semaglutide to determine if it helps people with HIV manage their weight after an initial weight loss phase. The study compares weight changes in those who continue semaglutide at a lower dose with those who stop using it. It also examines how well participants tolerate semaglutide over time. Individuals with HIV who have been stable on their treatment for at least six months and have a BMI of 30 or higher (or 27 with another weight-related health issue) might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not require you to stop your current medications, but you must have been on a stable dose of your antiretroviral therapy and any anti-inflammatory, blood-pressure, lipid, or glucose-lowering medications for at least 12 weeks before starting the study, with no plans to change the dose during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that semaglutide is generally safe for people with HIV. A large study found that most participants with HIV tolerated semaglutide well. Some experienced side effects like nausea or mild digestive issues, but these were usually manageable and did not cause major problems.
The FDA has already approved semaglutide for other uses, such as weight loss and diabetes management, indicating its safety for people without HIV.
Overall, the evidence suggests semaglutide is safe for people with HIV, but individual experiences may vary. It's important to discuss any concerns with healthcare providers.12345Why do researchers think this study treatment might be promising for weight management in people with HIV?
Researchers are excited about semaglutide for weight management in people with HIV because it offers a novel approach compared to current treatments. Unlike typical weight loss medications that might focus on appetite suppression or fat absorption, semaglutide is a GLP-1 receptor agonist, originally used for diabetes, which helps regulate appetite and glucose metabolism. This dual action could be particularly beneficial for people with HIV who often face unique metabolic challenges. Additionally, the treatment involves a structured dose escalation to optimize its effects, followed by a maintenance phase, which could lead to sustained weight management benefits. The potential for semaglutide to address weight management in this specific population is a major reason for the excitement surrounding this trial.
What evidence suggests that semaglutide might be an effective treatment for weight management in people with HIV?
Research has shown that semaglutide can help people with HIV lose a significant amount of weight. In several studies, weight loss results for people with HIV matched those in the general population. One study found that people with HIV lost about 6.47 kg (around 14 pounds) over a year while using semaglutide. Additionally, semaglutide lowered HbA1c, a measure of blood sugar levels, providing extra benefits for those concerned about diabetes. In this trial, participants will be assigned to different treatment arms: one group will receive semaglutide microdosing after initial dose escalation, while another group will not receive semaglutide after the initial dose escalation. Overall, semaglutide appears to be an effective and safe option for managing weight in people living with HIV.24678
Who Is on the Research Team?
Jordan Lake, MD, MSc
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for adults with HIV who are obese or overweight with related health issues. They must have stable HIV treatment, no recent medication changes for certain conditions, and a commitment to not start intensive diet or exercise programs during the study. Exclusions include severe weight fluctuations, diabetes treatments (except stable metformin), active eating disorders, specific genetic diseases, untreated thyroid issues, substance abuse affecting adherence, serious illness requiring hospitalization, known retinopathy, pregnancy plans during the study period.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants initiate semaglutide at 0.25 mg weekly with dose titration up to 2.0 mg weekly over 12 weeks
Microdosing
Participants receive semaglutide microdosing at 0.5 mg weekly or no semaglutide from weeks 13-60
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
Trial Overview
The trial tests if semaglutide microdosing prevents weight regain in people with HIV after initial weight loss. Participants will either continue with a low dose of semaglutide weekly or stop taking it after an induction phase where they receive higher doses up to 2 mg weekly. The study monitors tolerability and measures changes in weight and body composition over a total of 60 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive microdosing with semaglutide at 0.5 mg subcutaneously every week during weeks 13-60.
Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive no semaglutide during weeks 13-60.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Colorado Denver - Anschutz Medical Campus (UCD-AMC)
Collaborator
Massachusetts General Hospital (MGH)
Collaborator
Citations
Weight Loss Associated with Semaglutide Treatment ...
Semaglutide was associated with significant weight loss and HbA1c reduction among PWH, comparable to results of previous studies from the general population.
Semaglutide's Efficacy in Achieving Weight Loss for Those ...
The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH.
Semaglutide in people with HIV-associated lipohypertrophy
In recent studies of people with HIV, semaglutide has shown a similar degree of weight loss as in the general population, 4.
Do weight-loss drugs work for people with HIV?
In limited studies to date, semaglutide and other weight-loss drugs appear to be safe and effective for people living with HIV.
Clinical Research Update 11.21.23
Multivariate modeling indicated that semaglutide treatment was associated with significant bodyweight and percent bodyweight loss at 1 year (6.47 kg and 5.72%, ...
Glucagon-Like Peptide-1 Receptor Agonism for Persons ...
A large observational study from the CNICS (Centers for AIDS Research Network of Integrated Clinical Systems) cohort assessed the impact of semaglutide ...
Unraveling the safety and efficacy of semaglutide for ...
A recently published observational study from the United States utilizing data from the Centers for AIDS Research Network of Integrated Clinical ...
Glucagon-Like Peptide-1 Receptor Agonists in People With ...
Glucagon-Like Peptide-1 Receptor Agonists in People With Human Immunodeficiency Virus: An Expanded Meta-Analysis of Metabolic Outcomes ...
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