Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 16, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

December 31, 2026

Conditions
HIV InfectionsWeight Gain
Interventions
DRUG

Dapagliflozin 10mg Tab

Dapagliflozin will be administered as a comparator to the placebo to assess its effects on weight reduction

DRUG

Pitavastatin 4 Mg Oral Tablet

Pitavastatin tablets will be administered as a comparator to Rosuvastatin/Ezetimibe 10mg/10mg tablets to assess and compare their effects on LDL concentrations

DRUG

Rosuvastatin and Ezetimibe

Rosuvastatin/Ezetimibe 10mg/10mg tablets will be administered as a comparator to pitavastatin to assess and compare their effects on LDL concentrations

DRUG

Placebo

The placebo tablets are visually identical to the active drug tablets and will be administered as a comparator to Dapagliflozin.

Trial Locations (8)

2010

RECRUITING

St Vincent's Hospital, Sydney

3084

RECRUITING

Austin Health, Melbourne

7925

RECRUITING

Desmond Tutu Health Foundation, Cape Town

600113

RECRUITING

CART-CRS, Chennai

Unknown

RECRUITING

Universiti Malaya Medical Centre, Kuala Lumpur

RECRUITING

Institute of Human Virology, Nigeria, Abuja

RECRUITING

HIV-NAT, Bangkok

RECRUITING

University of Zimbabwe Clinical Research Centre, Harare

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Kirby Institute

OTHER_GOV

NCT06317051 - Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) | Biotech Hunter | Biotech Hunter