Incidence of HANA Conditions in HIV-infected Individuals

A Prospective Longitudinal Cohort Study to Determine the Incidence of HIV-associated Non-AIDS Conditions in Newly Diagnosed HIV-infected Individuals Initiating Integrase Inhibitor-based and Other Anti-retroviral Regimens

With the availability of effective anti-retroviral therapy, HIV-infected individuals are expected not to die of AIDS and have longer life expectancy. But at the same time, HIV-associated non-AIDS (HANA) conditions are becoming more important in their clinical management. It is currently uncertain whether patients started on different anti-retroviral regimens will have different incidence of HANA conditions.

This study aims to evaluate the incidence of various HANA conditions in a cohort of newly diagnosed HIV-infected individuals in Hong Kong initiating anti-retroviral treatment. The incidence of various HANA conditions will be evaluated for those receiving INSTI versus other non-INSTI-based regimens.

The HANA conditions evaluated will include 1. Hypertension 2. Diabetes and insulin resistance 3. Dyslipidemia 4. Lipodystrophy 5. Metabolic syndrome 6. Osteopenia and osteoporosis 7. Vitamin D deficiency 8. Renal impairment and kidney tubular dysfunction and 9. Liver fibrosis. Patients will be assessed prior to initiation of anti-retroviral therapy, and 48 weeks and 96 weeks after initiation of treatment. The incidence of development of each HANA condition will be determined and compared between those initiated different anti-retroviral regimens.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Vitamin D Deficiency; Renal Impairment; HIV; Osteoporosis; Osteopenia; Liver Fibroses

Detailed Description

This is a prospective, longitudinal, cohort study. 150 newly diagnosed HIV-infected individuals attending HIV clinics in Hong Kong will be recruited. Clinical assessment, and laboratory and imaging studies will be performed at baseline prior to initiation of anti-retroviral regimen, then annually thereafter for 5 years. Choice of anti-retroviral regimen will be decided by the in-charge HIV physician. Incidence of development of various HANA will be determined in those initiated INSTI-based regimens and other anti-retroviral regimens. An electronic platform will be used to formulate risk prediction for various clinical outcomes, and serve as a clinical decision support tool.

Statistical analysis;

1. The incidence rate of each HANA defined as above will be calculated as:
2. The incidence rate of each HANA will be determined for subjects started INSTI-based regimens and other non-INSTI-anti-retroviral regimens.
3. Variables, including demographic, clinical, treatment-related, and laboratory parameters, will be evaluated for association with development of various HANA, in univariate and multivariate analyses. Analyses will be performed for the whole cohort, and subgroup analyses will be performed in those initiated INSTI-based regimens and other non-INSTI-based regimens.

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All newly diagnosed HIV-infected patients meeting inclusion criteria, who attend the government HIV clinic, which is the largest HIV clinic in Hong Kong, over a 12-month period, will be invited to participate in this study. Subjects will also be referred by non-governmental organizations providing support to HIV-infected individuals at the time of diagnosis.

Description

Inclusion Criteria:

1. Confirmed HIV infection by HIV antibody or RNA test
2. Age ≥18 years old
3. Anti-retroviral treatment naïve
4. Agree to initiate anti-retroviral therapy (ART) as determined by in-charge HIV physician

Exclusion Criteria:

1. Pregnancy
2. Unable to give informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
INSTI; INSTI-containing ART regimens
non-INSTI; non-INSTI-containing ART regimens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalences of HIV-associated Non-AIDS Conditions (HANA)	Participants who were assessed at baseline and at least one of follow-up visits were included in the data analysis for prevalence of HIV-associated non-AIDS conditions (HANA) Prevalences of the following HIV-associated non-AIDS conditions (HANA) were assessed at baseline.; hypertension; diabetes mellitus; insulin resistance; dyslipidemia; metabolic syndrome; osteoporosis; osteopenia; vitamin D deficiency; renal disease; kidney tubular dysfunction; intermediate or advanced fibrosis (FIB-4 >1.3); advanced fibrosis (FIB-4 >2.67)	Baseline
Incidence Rates of HANA Conditions for At-risk Groups	Participants who were assessed at baseline and at least one of follow-up visits were included in the data analysis for incidence rates of HANA Incidence rates of following HANA conditions were reported among at-risk INSTI and non-INSTI-based antiretroviral therapy at 2 years.; hypertension; diabetes mellitus; insulin resistance; dyslipidemia; metabolic syndrome; osteopenia; osteoporosis; vitamin D deficiency; renal disease; kidney tubular dysfunction; intermediate or advanced fibrosis (FIB-4 > 1.3); advanced fibrosis (FIB-4 >2.67)	Enrollment to 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2018
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: March 25, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Liver Diseases; Insulin Resistance; Hyperinsulinism; Avitaminosis; Deficiency Diseases; Malnutrition; Fibrosis; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Osteoporosis; Metabolic Syndrome; Renal Insufficiency; Liver Cirrhosis; Vitamin D Deficiency; Bone Diseases, Metabolic
• Other Study ID Numbers: HANA protocol v.1 10Oct2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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