Incidence of HANA Conditions in HIV-infected Individuals

Recruiting

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

• Registration Number: NCT03483584
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-25
• Study First Submitted QC: 2018-03-25
• Study First Posted: 2018-03-30
• Study Start: 2018-04-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Confirmed HIV infection by HIV antibody or RNA test
2. Age ≥40 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HANA incidence	96 weeks	The incidence rates of HANA conditions which will be assessed.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Sha Tin, Hong Kong