Study S002702

A Phase III/IV Factorial Randomized Double-blind Trial to Compare the Addition of Dapagliflozin vs Placebo and Rosuvastatin/Ezetimibe Versus Pitavastatin in Patients With HIV on Integrase Strand Transfer Inhibitor-based Antiretrovirals With Elevated Metabolic Risk

ClinicalTrials.gov record

Registration

Registration: NCT06317051
Acronym: OPTIMAR
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: TRIPLE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 300
Start: 2024-12-16
Primary completion: 2026-07
Lead sponsor: Kirby Institute
Conditions: HIV Infections; Weight Gain
Interventions: DRUG:Dapagliflozin 10mg Tab; DRUG:Pitavastatin 4 Mg Oral Tablet; DRUG:Rosuvastatin and Ezetimibe; DRUG:Placebo
Results posted: FALSE

Registered primary outcomes

To assess the impact of dapagliflozin vs. placebo on weight reduction [24 weeks]
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration [24 weeks]

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