Clinical Outcomes in HIV With Comorbidities

Grace Lui

Status: Enrolling

Conditions: Hiv

Study type: Observational

Funder types: Other

Identifiers

NCT05824130

HIV ART study

Details and patient eligibility

About

Multi-arm, non-randomized, quality of life

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
3. Receiving ART regimens other than the combinations listed in Inclusion Criteria

Trial design

300 participants in 3 patient groups

B/F/TAF group

Description:

B/F/TAF

other INSTI-based ART regimen

Description:

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

non-INSTI-based ART regimen

Description:

2 NRTIs plus NNRTI or protease inhibitor