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This study is a pilot, open-lable, two-arm study. The investigators will enroll virally suppressed people living with HIV and obesity to evaluate the effect of tirzepatide on epigenetic aging, assessed by DNA methylation-based clocks using peripheral blood. In parallel, imaging studies will be performed to assess changes in body composition and intrahepatic fat content.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Participants enrolled in the interventional arm will undergo baseline imaging and blood testing, followed by an 8-week diet and nutrition consultation delivered via a smartphone-based application. Participants will then receive tirzepatide treatment for 25 weeks, after which imaging and blood testing will be repeated. Tirzepatide will subsequently be withheld for 24 weeks, with imaging and blood testing repeated once more to assess the persistence of treatment effect. Bictegravir PK/PD study will be done to assess whether tirzepatide will affect bictegravir pharmacokinetics during the study. |
|
| Standard of care | No Intervention | Participants enrolled in the standard of care arm will undergo identical imaging and blood testing, but without bictegravir PK/PD. They will receive diet and nutrition consult delivered via a smartphone-based application throughout the study course. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Tirzepatide will be given to the study arm after 8 weeks of diet and nutrition services. Study arm will receive a total of 25 weeks of tirzepatide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Second generation epigenetic aging clock | PCGrimAge will be used to study the measured epigetic age and differences with chronological age in years. | Baseline, week 33, week 57 |
| Third generation epigenetic aging clock | DunedinPACE will be used to assess the pace of aging, quantifying years of physiological decline per chronological year. | Baseline, week 33, week 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Intrahepatic triglycerides | Intrahepatic triglycerides will be measured using Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF). | Baseline, week 33, week 57 |
| Change in body composition assessed by dual-energy X-ray absorptiometry (DXA) |
| Measure | Description | Time Frame |
|---|---|---|
| Bictegravir pharmacokinetics (PK) | Bictegravir PK is assessed via serial blood sampling at 7 timepoints over 24 hours, with AUC constructed after calibrating serial drug levels. | Baseline, between week 16-32 |
| Tenofovir pharmacokinetics (PK) |
Inclusion Criteria:
- Adult people living with HIV, who are virally suppressed, defined as plasma HIV viral load is < 200 copies/mL within 6 months before enrollment. Participants have to have BMI > 30 kg/m2.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospial | Taipei | Taiwan |
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Lean body mass and fat mass will be measured in kilograms. |
| Baseline, week 33, week 57 |
| Change from baseline in body fat mass measured by bioelectrical impedance analysis (BIA) | Bioelectrical impedance analysis will be used to assess fat mass in kilograms. | Baseline, week 33, week 57 |
| Patient reported outcome | Patient reported outcome will be assessed using HIV symptom index | Baseline, week 33, week 57 |
| Drinking habits | Alcohol Use Disorders Identification Test (AUDIT) will be used to assess drinking habits for all participants. | Baseline, week 33, week 57 |
| Body weight | Body weight will be measured in kilograms. | Baseline, week 8, week 13, week 21, week 33, week 57 |
| Waist circumference | Waist circumference will be measured in centimeters | Baseline, week 8, week 13, week 21, week 33, week 57 |
| Inflammation markers | C-reactive protein will be measured in mg/dL. | Baseline, week 33, week 57 |
| Total bilirubin | Total bilirubin will be measured in mg/dL. | Baseline, week 33, week 57 |
| Alanine transaminase | ALT will be measured in U/L. | Baseline, week 33, week 57 |
| Aspartate transminase | AST will be measured in U/L. | Baseline, week 33, week 57 |
| Fibrosis-4 index | Fibrosis-4 index is calculated using AST, ALT, platelet and age. | Baseline, week 33, week 57 |
| A1c | HbA1c will be measured in percentage. | Baseline, week 33, week 57 |
| Fasting plasma glucose | Fasting plasma glucose will be measured in mg/dL. | Baseline, week 33, week 57 |
| Fasting serum insulin | Insulin will be measured in µIU/mL. | Baseline, week 33, week 57 |
| Change from baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | HOMA-IR will be calculated using fasting insulin and glucose. | Baseline, week 33, week 57 |
| Lipid profile | Lipid profile includes total cholesterol, HDL, LDL, TG measured in mg/dL. | Baseline, week 33, week 57 |
| Creatinine | Creatinine will be measured in mg/dL. | Baseline, week 33, week 57 |
| NT-proBNP | NT-proBNP will be measured in pg/L. | Baseline, week 33, week 57 |
| Blood pressure | Blood pressure will be measured in millimeter mercury. | Baseline, week 8, week 13, week 21, week 33, week 57 |
Tenofovir PK is assessed via serial blood sampling at 7 timepoints over 24 hours, with AUC constructed after calibrating serial drug levels
| Baseline, between week 16-32. |
| Emtricitabine pharmacokinetics (PK) | Emtricitabine PK is assessed via serial blood sampling at 7 timepoints over 24 hours, with AUC constructed after calibrating serial drug levels. | Baseline, between week 16-32 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D050171 | Dyslipidemias |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D050177 | Overweight |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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