Clinical Outcomes in HIV With Comorbidities

Recruiting

• Conditions: Hiv

• Registration Number: NCT05824130
• Lead Sponsor: Grace Lui

Brief Summary

Multi-arm, non-randomized, quality of life

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-04-05
• Study Start: 2023-04-13
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-04-21
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. HIV antibody positive
2. Age above 18 years
3. Diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases
4. 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

1. Recent diagnosis of AIDS within 6 months
2. Recent hospitalization for management of acute medical problems within 6 months
3. Receiving ART regimens other than the combinations listed in Inclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Low bone mineral density	Baseline	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.
Renal diseases	Baseline	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.
Liver steatosis and fibrosis	Baseline	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.
Cardiovascular risk	Baseline	High cardiovascular disease risk is defined as QRISK3 \>10%.; QRISK3 will be calculated from QRISK 3 risk calculator at qrisk.org.
Dyslipidemia	Baseline	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.
Health-related quality of life	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Incidences of Comorbidities	12 months or at the time of change of ART regimen	All the above endpoints will be determined at 1 year follow up or at the time of change of ART regimen

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong