Incidence of HANA Conditions in HIV-infected Individuals
|ClinicalTrials.gov Identifier: NCT03483584|
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : January 7, 2019
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.
|Condition or disease|
|HIV Metabolic Syndrome Osteopenia Osteoporosis Vitamin D Deficiency Renal Impairment Liver Fibroses|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official 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|
|Actual Study Start Date :||April 6, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
- HANA incidence [ Time Frame: 96 weeks ]The incidence rates of HANA conditions which will be assessed.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483584
|Contact: Rity Wongemail@example.com|
|Contact: Grace Luifirstname.lastname@example.org|
|Prince of Wales Hospital||Recruiting|
|Sha Tin, Hong Kong|
|Principal Investigator:||Grace Lui||CUHK|