Clinical Outcomes in HIV With Comorbidities

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824130
• Other study ID #: HIV ART study
• Status: Recruiting
• Start date: April 13, 2023
• Est. completion date: October 31, 2025

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Catherine Cheung, Mphil
• Phone: +852 35053376
• Email: catherinecheung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Multi-arm, non-randomized, quality of life

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Grace Lui

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cardiovascular risk	High cardiovascular disease risk is defined as QRISK3 >10%.; QRISK3 will be calculated from QRISK 3 risk calculator at qrisk.org.	Baseline
Primary	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
Primary	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
Primary	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	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