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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03483584
Other study ID # HANA protocol v.1 10Oct2017
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 6, 2018
Est. completion date March 31, 2024

Study information

Verified date August 2023
Source Chinese University of Hong Kong
Contact Rity Wong
Phone +85235053376
Email ritywong@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
Hong Kong Prince of Wales Hospital Sha Tin

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary HANA incidence The incidence rates of HANA conditions which will be assessed. 96 weeks
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