Clinical Outcomes in HIV With Comorbidities

NCT05824130 | Unknown

• 1 other identifier: HIV ART study
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-arm, non-randomized, quality of life

Conditions

Hiv

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Incidences of Comorbidities

  12 months or at the time of change of ART regimen

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with HIV (PLWH)

You may qualify if:

• 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

You may not qualify if:

• Recent diagnosis of AIDS within 6 months
• Recent hospitalization for management of acute medical problems within 6 months

Sponsors & Collaborators

• Grace Lui: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Grace Lui

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Cheung, Mphil

CONTACT

+852 35053376; catherinecheung@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Honorary Clinical Associate Professor

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 21, 2023
• Study Start: April 13, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)