Incidence of HANA Conditions in HIV-infected Individuals

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.

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Key information

Conditions

HIV Avitaminosis Bone Diseases Bone Diseases, Metabolic Deficiency Diseases Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Kidney Diseases Liver Cirrhosis Liver Diseases Liver Fibroses Male Urogenital Diseases Malnutrition Metabolic Diseases Metabolic Syndrome Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteopenia Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Impairment Renal Insufficiency Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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;

The incidence rate of each HANA defined as above will be calculated as:
The incidence rate of each HANA will be determined for subjects started INSTI-based regimens and other non-INSTI-anti-retroviral regimens.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnancy
Unable to give informed consent

Treatment and study plan

Primary outcomes

Prevalences of HIV-associated Non-AIDS Conditions (HANA)

Time frame: Baseline
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)
Incidence Rates of HANA Conditions for At-risk Groups

Time frame: Enrollment to 2 years
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)

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Mar 30, 2018
Registry last updated: Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed