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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.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INSTI | INSTI-containing ART regimens | ||
| non-INSTI | non-INSTI-containing ART regimens |
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| Measure | Description | Time Frame |
|---|---|---|
| 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.
| 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.
| Enrollment to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Grace Lui | CUHK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Shatin | Hong Kong |
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During the study period, a prospective and longitudinal cohort study involving People living with HIV (PLWH) recruited from the Infectious Diseases Clinic of the Prince of Wales Hospital, Hong Kong SAR, from April 2018 to May 2022. PLWH initiating or switching to a new ART regimen within 6 months were enrolled. Participants were assessed at baseline and followed up annually for 2 years to assess for the presence of various HANA conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | INSTI | Participants on INSTI-based antiretroviral therapy at baseline |
| FG001 | non-INSTI | Participants on non-INSTI-based antiretroviral therapy at baseline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
215 participants were recruited into the study. Those participants who had baseline and at least one follow-up visit during the two-year follow-up period were included in the data analyses. Those who had only one study visits were excluded from final analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | INSTI | INSTI-based antiretroviral therapy |
| BG001 | Non-INSTI | non-INSTI-based antiretroviral therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
| Participants who had baseline and at least one follow-up study visits were included in the analyses. | Posted | Count of Participants | Participants | No | Baseline |
|
At 96 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INSTI | INSTI-based antiretroviral therapy | 0 |
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Our study was limited by a small sample size, limiting power to compare outcomes between antiretroviral regimens. The study was started before Coronavirus disease 2019 (COVID-19) pandemic, and there were some lost to follow up after baseline visit due to pandemic social measures. The predominance of Asian male participants in this cohort may limit generalizability of the results to other ethnicity and women with HIV.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Grace Lui | The Chinese University of Hong Kong | +852 35051716 | gracelui@cuhk.edu.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2020 | Jul 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| D014808 | Vitamin D Deficiency |
| D051437 | Renal Insufficiency |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Peripheral blood samples
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Duration of HIV diagnosis | Median | Inter-Quartile Range | years |
|
| OG001 |
| non-INSTI |
non-INSTI based antiretroviral therapy |
|
|
|
| Primary | 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.
| At risk participants who had baseline and at least one follow-up study visits during the two-year period were included in the analysis. Incidence rates of HANA-conditions were reported in INSTI and non-INSTI groups. A person-year is a unit expressing the cumulative observation time during which the population is at risk for HANA conditions. Incidence rates are expressed as the number of new cases developing HANA conditions per 100 at-risk person-years during the study period. | Posted | Number | 95% Confidence Interval | cases per 100-persons years | Enrollment to 2 years |
|
|
|
|
| 139 |
| 0 |
| 139 |
| 0 |
| 139 |
| EG001 | non-INSTI | non-INSTI based antiretroviral therapy | 0 | 24 | 0 | 24 | 0 | 24 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Incidence rate of diabetes mellitus |
|
|
| Incidence rates of insulin resistance |
|
|
| Incidence rates of dyslipidemia |
|
|
| Incidence rates of metabolic syndrome |
|
|
| Incidence rates of osteopenia |
|
|
| Incidence rates of osteoporosis |
|
|
| Incidence rates of vitamin D deficiency |
|
|
| Incidence rates of renal diseases |
|
|
| Incidence rates of kidney tubular dysfunction |
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| Incidence rates of intermediate or advanced fibrosis (FIB-4 >1.3) |
|
|
| Incidence rates of advanced fibrosis (FIB-4 >2.67) |
|
|
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing hypertension in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 1.936 | 2-Sided | 95 | 0.251 | 14.919 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing diabetes mellitus in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 0.388 | 2-Sided | 95 | 0.099 | 1.155 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing diabetes mellitus in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 0.507 | 2-Sided | 95 | 0.132 | 1.948 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing insulin resistance in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 0.743 | 2-Sided | 95 | 0.395 | 1.397 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing insulin resistance in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 0.883 | 2-Sided | 95 | 0.444 | 1.759 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing dyslipidemia in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 1.187 | 2-Sided | 95 | 0.274 | 5.139 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing dyslipidemia in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 1.210 | 2-Sided | 95 | 0.257 | 5.688 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing metabolic syndrome in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 0.855 | 2-Sided | 95 | 0.196 | 3.739 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing metabolic syndrome in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 0.534 | 2-Sided | 95 | 0.108 | 2.631 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing osteopenia in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 1.396 | 2-Sided | 95 | 0.172 | 11.350 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing osteopenia in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 1.053 | 2-Sided | 95 | 0.119 | 9.317 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing osteoporosis in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 0 | 2-Sided | 95 | 0 | 0 | No incidence of osteoporosis was reported in non-INSTI group at 2 years. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing osteoporosis in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 0 | 2-Sided | 95 | 0 | 0 | No incidence of osteoporosis was reported in non-INSTI group at 2 years. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing vitamin D deficiency in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 2.198 | 2-Sided | 95 | 0.679 | 7.122 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing vitamin D deficiency in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 3.551 | 2-Sided | 95 | 0.850 | 14.833 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing renal diseases in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 1.197 | 2-Sided | 95 | 0.465 | 3.077 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing renal diseases in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 1.538 | 2-Sided | 95 | 0.510 | 4.638 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing kidney tubular dysfunction in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 1.166 | 2-Sided | 95 | 0.408 | 3.331 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing kidney tubular dysfunction in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 2.101 | 2-Sided | 95 | 0.615 | 7.180 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing intermediate or advanced fibrosis (FIB-4 > 1.3) in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 0.563 | 2-Sided | 95 | 0.159 | 1.995 | Wald chi square test is used to investigate whether INSTI group had a higher risk of developing of HANA conditions compared with non-INSTI group, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing intermediate or advanced fibrosis (FIB-4 > 1.3) in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 0.922 | 2-Sided | 95 | 0.244 | 3.493 | Wald chi square test is used to detect the difference in incidence rates in the INSTI group compared with the non-INSTI group (as reference group) after adjustment of covariates, with IRR >1 meaning higher risk of developing new HANA conditions. | Other | Poisson loglinear |
| Crude incidence rate ratio (IRR) was expressed as a ratio of incidence rates of developing advanced fibrosis (FIB-4 >2.67) in INSTI group compared with non-INSTI group as reference group at 2 years. | Incidence rate ratio | 0 | 2-Sided | 95 | 0 | 0 | No incidence in advanced fibrosis (FIB-4 >2.67) was reported in non-INSTI group at 2 years. | Other | Poisson loglinear |
| Adjusted Incidence rate ratio (IRR) was expressed as a ratio of incidence rate of developing advanced fibrosis (FIB-4 > 2.67) in INSTI group compared with non-INSTI group at 2 years after adjusted by age, sex, treatment-naive or experienced, duration of HIV diagnosis, baseline body weight and CD4 count. | Incidence rate ratio | 0 | 2-Sided | 95 | 0 | 0 | No incidence in advanced fibrosis (FIB-4 >2.67) was reported in non-INSTI group at 2 years. | Other | Poisson loglinear |