Clinical Outcomes in HIV With Comorbidities

NCT ID: NCT05824130

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-13

Study Completion Date

2025-10-31

Brief Summary

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Multi-arm, non-randomized, quality of life

Detailed Description

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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

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Hiv

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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B/F/TAF group

B/F/TAF

No interventions assigned to this group

other INSTI-based ART regimen

1-2 NRTI(s) plus an INSTI other than bictegravir

No interventions assigned to this group

non-INSTI-based ART regimen

2 NRTIs plus NNRTI or protease inhibitor

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. HIV antibody positive
2. Age above 18 years
3. Diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases
4. 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

Exclusion Criteria

1. Recent diagnosis of AIDS within 6 months
2. Recent hospitalization for management of acute medical problems within 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grace Lui

OTHER

Sponsor Role lead

Responsible Party

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Grace Lui

Honorary Clinical Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Grace Lui

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Catherine Cheung, Mphil

Role: CONTACT

+852 35053376

Other Identifiers

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HIV ART study

Identifier Type: -

Identifier Source: org_study_id

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