Clinical Outcomes in HIV With Comorbidities

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

Multi-arm, non-randomized, quality of life

Study Overview

• Status: Recruiting
• Conditions: Hiv

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Catherine Cheung, Mphil; Phone Number: +852 35053376; Email: catherinecheung@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People living with HIV (PLWH)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
B/F/TAF group; B/F/TAF
other INSTI-based ART regimen; 1-2 NRTI(s) plus an INSTI other than bictegravir
non-INSTI-based ART regimen; 2 NRTIs plus NNRTI or protease inhibitor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Grace Lui
• Investigators: Principal Investigator: Grace Lui, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HIV ART study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No