Clinical Outcomes in HIV With Comorbidities

Study Overview
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Brief Summary
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Multi-arm, non-randomized, quality of life

Detailed Description
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This is a prospective, longitudinal, observational study, performed at a Co-morbidities clinic for PLWH. PLWH with one or more co-morbidities receiving anti-retroviral therapy (ART) will be analyzed for their prevalence and incidence of developing renal, metabolic, hepatic and bone diseases. All participants will be assessed at baseline and followed up for one year, or until change in ART regimen, whichever earlier.

Official Title
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Renal, Metabolic, Hepatic and Bone Outcomes in People Living With HIV and Other Co-morbidities Receiving Different Anti-retroviral Regimens

Conditions
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Hiv

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV antibody positive Age above 18 years Diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases Receiving ART regimen, which consists of B/F/TAF, or 1-2 NRTI(s), plus another anti-retroviral drug, including INSTI other than bictegravir, NNRTI, or protease inhibitor Exclusion Criteria: Recent diagnosis of AIDS within 6 months Recent hospitalization for management of acute medical problems within 6 months Receiving ART regimens other than the combinations listed in Inclusion Criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B/F/TAF group<br>B/F/TAF | |
| other INSTI-based ART regimen<br>1-2 NRTI(s) plus an INSTI other than bictegravir | |
| non-INSTI-based ART regimen<br>2 NRTIs plus NNRTI or protease inhibitor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal diseases | Renal disease is defined as glomerular filtration rate (GFR) <60 mL/min/1.73m2, or presence of albuminuria, defined as urine albumin:creatinine >3 mg/mmol, according to Kidney Disease Improving Global Outcomes (KDIGO) categorization of chronic kidney disease. Blood will be taken for creatinine and urine for creatinine and albumin levels. | Baseline | 
| Dyslipidemia | Dyslipidemia is defined as total cholesterol >5.17 mmol/l, triglyceride >1.7 mmol/l, HDL cholesterol <1.03 mmol/l in men and <1.29 mmol/l in women, or LDL cholesterol >4.1 mmol/l, or a history of taking anti-hyperlipidemic drugs, according to the National Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) guidelines. Fasting blood sample will be taken to measure total, LDL and HDL cholesterol and triglyceride levels. | Baseline | 
| Cardiovascular risk | High cardiovascular disease risk is defined as QRISK3 >10%. QRISK3 will be calculated from QRISK 3 risk calculator at qrisk.org. | Baseline | 
| Liver steatosis and fibrosis | Liver steatosis is defined as Controlled Attenuated Parameter (CAP) >248 dB/m and significant fibrosis is defined as liver stiffness >9.0 kPa, as measured by transient elastography. Transient elastography will be performed to measure CAP and liver stiffness. | Baseline | 
| Low bone mineral density | Low bone mineral density is defined as T score <-1.0 in men 50 years and in post-menopausal women at either lumbar spine or femoral neck, and Z score <-2.0 in men younger than 50 years and pre-menopausal women, as measured by dual energy X-ray absorptiometry (DXA). DXA scan will be performed to measure bone mineral density at lumbar spine and femoral neck. | Baseline | 
| Health-related quality of life | any severity of problem in the five dimensions of EQ-5D-5L, EQ-5D-5L index and EQ-VAS EuroQol 5 level EQ-5D version will be performed to measure the above parameters. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Comorbidities | All the above endpoints will be determined at 1 year follow up or at the time of change of ART regimen | 12 months or at the time of change of ART regimen |