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Trial Outcomes & Findings for Incidence of HANA Conditions in HIV-infected Individuals (NCT NCT03483584)

NCT ID: NCT03483584

Last Updated: 2025-12-09

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

215 participants

Primary outcome timeframe

Enrollment to 2 years

Results posted on

2025-12-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure
INSTI
Participants on INSTI-based antiretroviral therapy at baseline
non-INSTI
Participants on non-INSTI-based antiretroviral therapy at baseline
Overall Study
STARTED
183
32
Overall Study
At year 1
131
22
Overall Study
At year 2
110
21
Overall Study
COMPLETED
139
24
Overall Study
NOT COMPLETED
44
8

Reasons for withdrawal

Reasons for withdrawal
Measure
INSTI
Participants on INSTI-based antiretroviral therapy at baseline
non-INSTI
Participants on non-INSTI-based antiretroviral therapy at baseline
Overall Study
Lost to Follow-up
40
7
Overall Study
Withdrawal by Subject
4
1

Baseline Characteristics

Incidence of HANA Conditions in HIV-infected Individuals

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
INSTI
n=183 Participants
INSTI-based antiretroviral therapy
Non-INSTI
n=32 Participants
non-INSTI-based antiretroviral therapy
Total
n=215 Participants
Total of all reporting groups
Duration of HIV diagnosis
0.8 years
n=4 Participants
7.7 years
n=50 Participants
1.0 years
n=518 Participants
Age, Continuous
46.3 years
STANDARD_DEVIATION 14.5 • n=4 Participants
48.8 years
STANDARD_DEVIATION 12.7 • n=50 Participants
46.7 years
STANDARD_DEVIATION 14.2 • n=518 Participants
Sex: Female, Male
Female
23 Participants
n=4 Participants
4 Participants
n=50 Participants
27 Participants
n=518 Participants
Sex: Female, Male
Male
160 Participants
n=4 Participants
28 Participants
n=50 Participants
188 Participants
n=518 Participants
Race/Ethnicity, Customized
Chinese
174 Participants
n=4 Participants
30 Participants
n=50 Participants
204 Participants
n=518 Participants
Race/Ethnicity, Customized
Non-Chinese
9 Participants
n=4 Participants
2 Participants
n=50 Participants
11 Participants
n=518 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Participants who had baseline and at least one follow-up study visits were included in the analyses.

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)

Outcome measures

Outcome measures
Measure
INSTI
n=139 Participants
INSTI-based antiretroviral therapy
non-INSTI
n=24 Participants
non-INSTI based antiretroviral therapy
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of hypertension
69 Participants
15 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of diabetes mellitus
30 Participants
4 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of insulin resistance
79 Participants
9 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of dyslipidemia
85 Participants
17 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of metabolic syndrome
60 Participants
16 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of osteopenia
72 Participants
9 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of osteoporosis
6 Participants
1 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of vitamin D deficiency
27 Participants
3 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of renal diseases
58 Participants
9 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of kidney tubular dysfunction
55 Participants
9 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of intermediate or advanced fibrosis (FIB-4 >1.3)
42 Participants
10 Participants
Prevalences of HIV-associated Non-AIDS Conditions (HANA)
Prevalence of advanced fibrosis (FIB-4 >2.67)
5 Participants
1 Participants

PRIMARY outcome

Timeframe: Enrollment to 2 years

Population: 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.

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)

Outcome measures

Outcome measures
Measure
INSTI
n=139 Participants
INSTI-based antiretroviral therapy
non-INSTI
n=24 Participants
non-INSTI based antiretroviral therapy
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of hypertension
14.7 cases per 100-persons years
Interval 9.5 to 22.8
10.5 cases per 100-persons years
Interval 2.6 to 42.1
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rate of diabetes mellitus
3.3 cases per 100-persons years
Interval 1.6 to 6.9
9.5 cases per 100-persons years
Interval 3.6 to 25.4
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of insulin resistance
31.6 cases per 100-persons years
Interval 22.9 to 43.6
41.9 cases per 100-persons years
Interval 24.4 to 72.2
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of dyslipidemia
16.5 cases per 100-persons years
Interval 10.3 to 26.6
14.3 cases per 100-persons years
Interval 3.6 to 57.1
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of metabolic syndrome
9.9 cases per 100-persons years
Interval 5.9 to 16.4
11.8 cases per 100-persons years
Interval 2.9 to 47.0
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of osteopenia
5.1 cases per 100-persons years
Interval 2.4 to 10.7
3.4 cases per 100-persons years
Interval 0.5 to 24.5
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of osteoporosis
1.1 cases per 100-persons years
Interval 0.4 to 3.5
0 cases per 100-persons years
Interval 0.0 to 0.0
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of vitamin D deficiency
16.7 cases per 100-persons years
Interval 12.1 to 22.9
7.1 cases per 100-persons years
Interval 2.3 to 22.1
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of renal diseases
20.1 cases per 100-persons years
Interval 14.2 to 28.6
17.2 cases per 100-persons years
Interval 7.2 to 41.4
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of kidney tubular dysfunction
16.3 cases per 100-persons years
Interval 11.2 to 23.9
13.3 cases per 100-persons years
Interval 5.0 to 35.3
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of intermediate or advanced fibrosis (FIB-4 >1.3)
6.7 cases per 100-persons years
Interval 3.8 to 11.8
11.5 cases per 100-persons years
Interval 3.7 to 35.8
Incidence Rates of HANA Conditions for At-risk Groups
Incidence rates of advanced fibrosis (FIB-4 >2.67)
1.9 cases per 100-persons years
Interval 0.8 to 4.6
0 cases per 100-persons years
Interval 0.0 to 0.0

Adverse Events

INSTI

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

non-INSTI

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Grace Lui

The Chinese University of Hong Kong

Phone: +852 35051716

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place