Incidence of HANA Conditions in HIV-infected Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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|