Incidence of HANA Conditions in HIV-infected Individuals

NCT03483584 | Completed Results

• 1 other identifier: HANA protocol v.1 10Oct2017
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Metabolic Syndrome; Osteopenia; Osteoporosis; Vitamin D Deficiency; Renal Impairment; Liver Fibroses

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

INSTI

INSTI-containing ART regimens

non-INSTI

non-INSTI-containing ART regimens

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

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.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Unable to give informed consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples

MeSH Terms

Conditions

Metabolic Syndrome; Bone Diseases, Metabolic; Osteoporosis; Vitamin D Deficiency; Renal Insufficiency; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Our study was limited by a small sample size, limiting power to compare outcomes between antiretroviral regimens. The study was started before Coronavirus disease 2019 (COVID-19) pandemic, and there were some lost to follow up after baseline visit due to pandemic social measures. The predominance of Asian male participants in this cohort may limit generalizability of the results to other ethnicity and women with HIV.

Results Point of Contact

• Title: Prof. Grace Lui
• Organization: The Chinese University of Hong Kong

gracelui@cuhk.edu.hk

+852 35051716

Study Officials

• Grace Lui

  CUHK

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: March 30, 2018
• Study Start: April 6, 2018
• Primary Completion: March 31, 2024
• Study Completion: September 30, 2024
• Last Updated: December 9, 2025
• Results First Posted: December 9, 2025

Record last verified: 2025-11

Locations

HK (1)