HIVNCT03483584
Incidence of HANA Conditions in HIV-infected Individuals
An observational study of HIV and Metabolic Syndrome, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Metabolic Syndrome, Osteopenia
- How many people
- 215 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Apr 2018to 30 Sep 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All newly diagnosed HIV-infected patients meeting inclusion criteria, who attend the government HIV clinic, which is the largest HIV clinic in Hong Kong, over a 12-month period, will be invited to participate in this study. Subjects will also be referred by non-governmental organizations providing support to HIV-infected individuals at the time of diagnosis.
Who may be able to join
- Confirmed HIV infection by HIV antibody or RNA test
- Age ≥18 years old
- Anti-retroviral treatment naïve
- Agree to initiate anti-retroviral therapy (ART) as determined by in-charge HIV physician
Who cannot join
- Pregnancy
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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;
- The incidence rate of each HANA defined as above will be calculated as:
- The incidence rate of each HANA will be determined for subjects started INSTI-based regimens and other non-INSTI-anti-retroviral regimens.
- 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.
- Conditions
- HIV, Metabolic Syndrome, Osteopenia, Osteoporosis, Vitamin D Deficiency, Renal Impairment
- Medical subject headings
- Metabolic Syndrome, Bone Diseases, Metabolic, Osteoporosis, Vitamin D Deficiency, Renal Insufficiency, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| INSTI | INSTI-containing ART regimens | |
| non-INSTI | non-INSTI-containing ART regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Participants who were assessed at baseline and at least one of follow-up visits were included in the data analysis for prevalence of HIV-associated non-AIDS conditions (HANA)
Prevalences of the following HIV-associated non-AIDS conditions (HANA) were assessed at baseline.
- hypertension
- diabetes mellitus
- insulin resistance
- dyslipidemia
- metabolic syndrome
- osteoporosis
- osteopenia
- vitamin D deficiency
- renal disease
- kidney tubular dysfunction
- intermediate or advanced fibrosis (FIB-4 >1.3)
- advanced fibrosis (FIB-4 >2.67)
Measured: Baseline
Incidence Rates of HANA Conditions for At-risk Groups
Participants who were assessed at baseline and at least one of follow-up visits were included in the data analysis for incidence rates of HANA
Incidence rates of following HANA conditions were reported among at-risk INSTI and non-INSTI-based antiretroviral therapy at 2 years.
- hypertension
- diabetes mellitus
- insulin resistance
- dyslipidemia
- metabolic syndrome
- osteopenia
- osteoporosis
- vitamin D deficiency
- renal disease
- kidney tubular dysfunction
- intermediate or advanced fibrosis (FIB-4 > 1.3)
- advanced fibrosis (FIB-4 >2.67)
Measured: Enrollment to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start6 Apr 2018
- Primary completion31 Mar 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lui, Chinese University of Hong Kong
- Investigators
- Grace Lui, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483584
- Sponsor's protocol ID
- HANA protocol v.1 10Oct2017
- Status last verified
- Nov 2025
- First submitted
- 25 Mar 2018
- Last updated
- 9 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided