Incidence of HANA Conditions in HIV-infected Individuals

The Chinese University of Hong Kong

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT03483584

HANA protocol v.1 10Oct2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

215 participants in 2 patient groups

INSTI

Description:

INSTI-containing ART regimens

non-INSTI

Description:

non-INSTI-containing ART regimens