This is a randomized, double-blinded, placebo-controlled phase 2b clinical trial to characterize, examine and compare the effects of GLP-1 receptor agonist (semaglutide) in HIV-infected adult individuals with lipohypertrophy versus healthy controls with obesity but without HIV.
The two populations will be studied in separate but similarly-designed studies running in parallel.
Subjects in both populations will be assigned by chance (1:1) to semaglutide or placebo.
Emphysema is a type of Chronic Obstructive Pulmonary Disease (COPD) and a major cause of death. Studies suggest that emphysema is more common in HIV positive people (HIV+) compared to HIV negative (HIV-) people. The purpose of this research study is to determine whether emphysema in HIV+ patients is clinically and biologically different compared to emphysema in those without HIV.
HIV testing is often shunned in community settings due to the stigma of HIV-centric services. Our recent pilot study strongly suggest that integration of a package of screening that include HIV, diabetes, and hypertension hold promise of substantially increasing the uptake of HIV testing while simultaneously providing direly needed community screening for non-communicable disease (NCDs) like diabetes and hypertension, which themselves are at epidemic levels in Sub-Saharan Africa. This study will examine whether integrating HIV screening with NCD screening will improve uptake of HIV testing and whether integrating HIV and NCD care will improve retention.
Treatment of chronic hepatitis C virus (HCV) infection is now possible with all oral medications. While most patients achieve a sustained virologic response (SVR) after treatment, synonymous with cure, some patients relapse after treatment for reasons that are unclear. The goal of this research is to understand how a person's immune system changes during treatment of HCV infection with all oral therapy, and how these changes might impact the chances of relapse after treatment. To address these questions, blood and clinical information will be collected from study participants over the course of receiving standard of care treatment for HCV infection. This blood and clinical information will be used to conduct laboratory research focused on the immune system.
To maximize the public health benefit of expenditures on HIV prevention, treatment and care in Sub Saharan Africa programs are needed that synergistically combine intervention strategies, target the intensity of interventions to attributable risk, support couples to reduce their risk of HIV transmission within the partnership, and facilitate safe and acceptable uptake of available treatment and prevention services. The goal of this study is to advance methodological innovations in the support of cost- effective combination HIV prevention programs.
The study will develop reliable indicators for intervention exposure using biometric identifiers, develop indicators that capture dynamic multi-component risk reduction strategies, establish proof of concept for the combination and scalability of proven HIV intervention components never before brought to scale (HIV self-testing, PrEP for discordant couples), carefully assess the safety and acceptance of the strategy, and examine important operational issues related to comparative cost and efficiency of competing strategies.
The study will be conducted in Kisarawe, Tanzania. The intervention, if found efficacious, would provide needed program and policy guidance highly significant to public health. In addition, if these strategies being explored are proven to be effective it could lead to substantial savings to US programs that support
global AIDS control and treatment.