Metabolic Abnormalities, Telmisartan, and HIV Infection
Creators: name: University Of California Office Of The President
Publisher: name: University of California Office of the President
publisherIdentifier: https://ror.org/00dmfq477
publisherIdentifierScheme: ROR
Year: 2024

description: Background: HIV-positive patients are at increased risk for disease of the heart and blood vessels. Both HIV and the medications used to treat HIV (ART) may contribute to this increased risk. Changes in body chemistry such as diabetes, high cholesterol, and changes in the location of body fat (lipodystrophy) also contribute to this risk, and are common in HIV-positive patients both on and off ART. It is not fully understood why these changes occur, but they may be partly related to abnormalities in the way the body controls how fat cells work. The treatment of these changes in body chemistry and fat is difficult, and the FDA has not approved any drugs specifically to treat excess fat under the skin (SAT) and in the organs (visceral adipose tissue or VAT). When people have excess fat in the abdominal area we call this lipohypertrophy. Telmisartan is a drug that is approved for the treatment of high blood pressure, but that also has effects on fat cells. Telmisartan has been shown to decrease VAT, and improve cholesterol levels and certain types of inflammation in HIV-negative patients who have these medical problems. Telmisartan has been studied in people with and without high blood pressure, and is safe for both types of people. Telmisartan has not specifically been studied in people with HIV, but, because of the way it works, is a promising option for the treatment of HIV- and ART-related changes in body chemistry and fat. Study Design: 35 people who have HIV infection, an undetectable viral load on ART, and fat gain in their abdomen will be given telmisartan 40mg once daily for 24 weeks. CAT scans will be performed at the start and end of therapy. The amount of VAT in the abdomen will be calculated from these scans and compared. We hope to see a 10% decrease in VAT with telmisartan therapy. We will also monitor blood pressure and blood samples to make sure patients are not experiencing negative side effects from telmisartan. Analysis Plan: The effects of telmisartan on VAT volume and the safety and tolerability of telmisartan in HIV-positive subjects will be the primary outcomes. Changes in SAT, VAT:SAT ratio, markers of inflammation, cholesterol levels, rates of diabetes, and heart disease risk will also be studied. Significance and Implications: With highly-active ART, many HIV-infected patients can be expected to live long, relatively healthy lives, and effective treatments for the long-term complications of HIV and ART are needed. These complications are important to study, as HIV infection, ART, and lipodystrophy have all been associated with increased risk for heart disease. As mentioned, increased VAT is associated many changes in body chemistry, but treatment options remain limited. If improvement is demonstrated with telmisartan, it will be the only medication in pill form capable of treating multiple body chemistry and fat changes in people living with HIV. This study is the first step towards understanding if telmisartan has the potential to help treat these important problems.