Human immunodeficiency virus (HIV) Infection and Obesity MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Semaglutide
Product Name: Ozempic (semaglutide)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Semaglutide
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Con
Sponsors
University College Dublin (UCD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Be over 18 years old • Be HIV-1 antibody positive as determined by a positive 3rd or 4th generation Ag/Ab ELISA assay • Be on stable ART for at least 2 years, with the last two viral loads =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Subjects unable to comply with the study protocol or unable to selfadminister subcutaneous semaglutide • History of obesity induced by other endocrine disorders: Cushing’s syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma • Subjects with a diagnosis of diabetes mellitus who either have proliferative retinopathy or maculopathy requiring treatment or have not undergone retinal screening within the previous 12 months. • History hypothyroidism that has recently been poorly-controlled, defined as a TSH 10 mU/L within the last 12 months • Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin) • History of severe renal impairment, as defined by a baseline creatinine clearance 9) • Subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) coinfection • Any active illness (including AIDS-defining illness), which in the opinion of the investigator precludes participation in the study • History of cancer (apart from treated Kaposi’s Sarcoma) and/or receiving chemotherapy or radiotherapy • Active illicit intravenous drug use • Subjects concurrently enrolled in another clinical trial of an investigational medicinal product • The investigator may decide that a subject cannot proceed in the study if there are any relevant other abnormal results in the screening assessments • Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide • Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat • For female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in total and subcutaneous fat, as measured by DXA at week 28. Changes from baseline to week 28 in markers of B-cell function, T-cell function, innate immunity, inflammation, gut microbiome composition, adipose tissue function, cholesterol and glucose metabolism and HIV RNA and HIV viral reservoir. The proportion of subjects in both arms not achieving = 5% weight loss from baseline at week 16. Proportion with reported AE/AR, SAE/SAR Change in health-related quality of life (QOL) at week 28. Change in PR interval (sec) on ECG from baseline to week 4 stratified by class of antiretrovirals ;Timepoint(s) of evaluation of this end point: Week 4, Week 16 and Week 28 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of GLP- 1 analogue therapy (subcutaneous semaglutide) as an adjunct to diet and exercise in achieving greater weight loss in people living with HIV and obesity (PLWHO) as compared to diet and exercise alone.;Secondary Objective: To explore the effect of GLP-1 analogue therapy on markers of inflammation, immune function and HIV viral reservoirs in PLWHO. To explore the effect of GLP-1 analogue therapy on markers of glucose and lipid metabolism in PLWHO. To explore the effect of GLP-1 analogue therapy on markers of gut microbial translocation in PLWHO. To assess the safety of semaglutide therapy in PLWHO on stable ART.;Primary end point(s): Change from baseline in total body weight at week 28.;Timepoint(s) of evaluation of this end point: Week 28 | — |
Countries
Ireland
Contacts
Public ContactDepartment of Infectious Diseases
University College Dublin
Outcome results
None listed