Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06317051 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: OPTIMAR
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion date: Dec 2026 to Dec 2027
    • Study description expanded, about 84 words
    v6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 8 to 10
    v5
  3. Study sites: 6 to 8v4
  4. Study sites: 3 to 6v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jul 2025 to Jul 2026
    • Start date changed from estimate of Aug 2024 to Dec 16, 2024
    • Study sites: 0 to 3
    • Eligibility criteria expanded, about 1 word
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
People with HIV are at a higher risk of cardiovascular diseases (CVD) due to the effects of the virus and its treatment. Integrase strand transfer inhibitors (INSTIs), a common HIV treatment, are associated with increased CVD risk and metabolic issues, such as weight gain and high blood pressure. Sodium-glucose cotransporter 2 (SGLT2) inhibitors, however, have been working well in reducing CVD events and hospitalizations due to heart failure, irrespective of diabetes presence. They also help in reducing weight and blood pressure. Pitavastatin has shown to work in lowering CVD events in people with HIV, but its availability is limited. This benefit is thought to be common to all statins, but this has not yet been confirmed. This study will examine the impact of dapagliflozin vs. placebo on metabolic parameters in people with HIV with high metabolic risk who are on INSTI-based ART.
Trial Details
NCT Number NCT06317051
Lead Sponsor Kirby Institute
Conditions
(from sponsor)		 HIV Infections, Weight Gain
Related terms HIV Infections, Weight Gain
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov