HivNCT05824130
Clinical Outcomes in HIV With Comorbidities
An observational study of Hiv, run by Grace Lui at 1 site in Hong Kong.
Trial summary
Multi-arm, non-randomized, quality of life Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv
- How many people
- 300 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Apr 2023to 31 Oct 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: People living with HIV (PLWH)
Who may be able to join
- HIV antibody positive
- Age above 18 years
- Diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases
- Receiving ART regimen, which consists of B/F/TAF, or 1-2 NRTI(s), plus another anti-retroviral drug, including INSTI other than bictegravir, NNRTI, or protease inhibitor
Who cannot join
- Recent diagnosis of AIDS within 6 months
- Recent hospitalization for management of acute medical problems within 6 months
- Receiving ART regimens other than the combinations listed in Inclusion Criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal, Metabolic, Hepatic and Bone Outcomes in People Living With HIV and Other Co-morbidities Receiving Different Anti-retroviral Regimens
Multi-arm, non-randomized, quality of life
Read the detailed description
This is a prospective, longitudinal, observational study, performed at a Co-morbidities clinic for PLWH. PLWH with one or more co-morbidities receiving anti-retroviral therapy (ART) will be analyzed for their prevalence and incidence of developing renal, metabolic, hepatic and bone diseases. All participants will be assessed at baseline and followed up for one year, or until change in ART regimen, whichever earlier.
- Conditions
- Hiv
- Medical subject headings
- Acquired Immunodeficiency Syndrome
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 |
|---|---|---|
| B/F/TAF group | B/F/TAF | |
| other INSTI-based ART regimen | 1-2 NRTI(s) plus an INSTI other than bictegravir | |
| non-INSTI-based ART regimen | 2 NRTIs plus NNRTI or protease inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal diseases
Renal disease is defined as glomerular filtration rate (GFR) <60 mL/min/1.73m2, or presence of albuminuria, defined as urine albumin:creatinine >3 mg/mmol, according to Kidney Disease Improving Global Outcomes (KDIGO) categorization of chronic kidney disease.
Blood will be taken for creatinine and urine for creatinine and albumin levels.
Measured: Baseline
Dyslipidemia
Dyslipidemia is defined as total cholesterol >5.17 mmol/l, triglyceride >1.7 mmol/l, HDL cholesterol <1.03 mmol/l in men and <1.29 mmol/l in women, or LDL cholesterol >4.1 mmol/l, or a history of taking anti-hyperlipidemic drugs, according to the National Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) guidelines.
Fasting blood sample will be taken to measure total, LDL and HDL cholesterol and triglyceride levels.
Measured: Baseline
Cardiovascular risk
High cardiovascular disease risk is defined as QRISK3 >10%.
QRISK3 will be calculated from QRISK 3 risk calculator at qrisk.org.
Measured: Baseline
Liver steatosis and fibrosis
Liver steatosis is defined as Controlled Attenuated Parameter (CAP) >248 dB/m and significant fibrosis is defined as liver stiffness >9.0 kPa, as measured by transient elastography.
Transient elastography will be performed to measure CAP and liver stiffness.
Measured: Baseline
Low bone mineral density
Low bone mineral density is defined as T score <-1.0 in men 50 years and in post-menopausal women at either lumbar spine or femoral neck, and Z score <-2.0 in men younger than 50 years and pre-menopausal women, as measured by dual energy X-ray absorptiometry (DXA).
DXA scan will be performed to measure bone mineral density at lumbar spine and femoral neck.
Measured: Baseline
Health-related quality of life
any severity of problem in the five dimensions of EQ-5D-5L, EQ-5D-5L index and EQ-VAS
EuroQol 5 level EQ-5D version will be performed to measure the above parameters.
Measured: Baseline
Secondary outcomes (1)
Incidences of Comorbidities
All the above endpoints will be determined at 1 year follow up or at the time of change of ART regimen
Measured: 12 months or at the time of change of ART regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start13 Apr 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Grace Lui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grace Lui, Chinese University of Hong Kong
- Investigators
- Grace Lui, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824130
- Sponsor's protocol ID
- HIV ART study
- Status last verified
- Aug 2023
- First submitted
- 5 Apr 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal, Metabolic, Hepatic and Bone Outcomes in People Living With HIV and Other Co-morbidities Receiving Different Anti-retroviral Regimens
- ClinicalTrials.gov ID
- NCT05824130
- Acronym / sponsor ID
- HIV ART study
- Conditions
- Hiv
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Grace LuiUniversity, hospital or other
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-arm, non-randomized, quality of life
Detailed description
This is a prospective, longitudinal, observational study, performed at a Co-morbidities clinic for PLWH. PLWH with one or more co-morbidities receiving anti-retroviral therapy (ART) will be analyzed for their prevalence and incidence of developing renal, metabolic, hepatic and bone diseases. All participants will be assessed at baseline and followed up for one year, or until change in ART regimen, whichever earlier.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B/F/TAF group | – | –B/F/TAF |
| other INSTI-based ART regimen | – | –1-2 NRTI(s) plus an INSTI other than bictegravir |
| non-INSTI-based ART regimen | – | –2 NRTIs plus NNRTI or protease inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV (PLWH)
Key inclusion criteria (4 listed)
- HIV antibody positive
- Age above 18 years
- Diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases
- Receiving ART regimen, which consists of B/F/TAF, or 1-2 NRTI(s), plus another anti-retroviral drug, including INSTI other than bictegravir, NNRTI, or protease inhibitor
Key exclusion criteria (3 listed)
- Recent diagnosis of AIDS within 6 months
- Recent hospitalization for management of acute medical problems within 6 months
- Receiving ART regimens other than the combinations listed in Inclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal diseases
Time frame: Baseline
Renal disease is defined as glomerular filtration rate (GFR) <60 mL/min/1.73m2, or presence of albuminuria, defined as urine albumin:creatinine >3 mg/mmol, according to Kidney Disease Improving Global Outcomes (KDIGO) categorization of chronic kidney disease. Blood will be taken for creatinine and urine for creatinine and albumin levels.
Dyslipidemia
Time frame: Baseline
Dyslipidemia is defined as total cholesterol >5.17 mmol/l, triglyceride >1.7 mmol/l, HDL cholesterol <1.03 mmol/l in men and <1.29 mmol/l in women, or LDL cholesterol >4.1 mmol/l, or a history of taking anti-hyperlipidemic drugs, according to the National Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) guidelines. Fasting blood sample will be taken to measure total, LDL and HDL cholesterol and triglyceride levels.
Cardiovascular risk
Time frame: Baseline
High cardiovascular disease risk is defined as QRISK3 >10%. QRISK3 will be calculated from QRISK 3 risk calculator at qrisk.org.
Liver steatosis and fibrosis
Time frame: Baseline
Liver steatosis is defined as Controlled Attenuated Parameter (CAP) >248 dB/m and significant fibrosis is defined as liver stiffness >9.0 kPa, as measured by transient elastography. Transient elastography will be performed to measure CAP and liver stiffness.
Low bone mineral density
Time frame: Baseline
Low bone mineral density is defined as T score <-1.0 in men 50 years and in post-menopausal women at either lumbar spine or femoral neck, and Z score <-2.0 in men younger than 50 years and pre-menopausal women, as measured by dual energy X-ray absorptiometry (DXA). DXA scan will be performed to measure bone mineral density at lumbar spine and femoral neck.
Health-related quality of life
Time frame: Baseline
any severity of problem in the five dimensions of EQ-5D-5L, EQ-5D-5L index and EQ-VAS EuroQol 5 level EQ-5D version will be performed to measure the above parameters.
1 secondary outcome
Incidences of Comorbidities
Time frame: 12 months or at the time of change of ART regimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Lui principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv, run by Grace Lui at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Cheung, Mphil (+852 35053376, catherinecheung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal diseases (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.