We are looking for adults with HIV to see if a medicine called tesamorelin can improve physical strength and muscle health when used with exercise. We will also want to see how it impacts people’s lives and see if the benefits last after people stop taking the medicine.
People living with HIV may feel weaker, move slower sooner, and get tired more easily than people without HIV. Some may lose weight or strength over time. Exercise can help, but it often doesn't work as well for people living with HIV and can be hard to stick with. This study wants to see if a medicine called tesamorelin can help people with HIV get stronger and improve their muscle health when used with exercise. Tesamorelin is already approved by the FDA to treat belly fat in people with HIV. It may also help build muscle. But we don't know yet if it helps people move better or feel stronger. If you join this study, you will be randomly placed into one of two groups. The first group will take tesamorelin and the other group will take a placebo. A placebo looks like the study drug but doesn't have any active medicine. Everyone will do a home workout plan with help from an exercise coach for 24 weeks. You will check-in with your coach virtually twice per week. After that, there will be another 24 weeks when you won't take the study medicine or work with a coach, but you'll be encouraged to keep exercising on your own. You will check in once per month. During the study, you will come in for 11 in-person visits. At some of these visits, you may be asked to fill out surveys about your health and the medicines you take. You might also have a physical exam, a CT scan, a strength and balance test, a small muscle sample taken (called a biopsy), or a bone scan called a DXA scan. The CT scan takes pictures of the fat and muscle in your belly and thigh. For the muscle biopsy, we will take a small piece of muscle from your leg using a special tool. A DXA scan is a type of x-ray scan that shows how thick your bones are (bone density) and how much fat and muscle you have in your body. You also will be asked to keep track of your exercise and wear a FitBit to track your heart rate and step count.
You may be able to join this study if you are an adult between the ages of 50 and 80 years old and living with HIV. To take part, you should not be doing strenuous physical activity, like exercise that makes you sweat, more than 3 days a week.
Protocol Number: 24-2016
More information available at ClinicalTrials.gov: NCT06554717
Principal Investigator