At a glance
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Treatment of Early Hypertension Among Persons Living With HIV in Haiti
In Brief
A Phase 2 clinical trial evaluating Amlodipine 5mg for HIV/AIDS and Pre Hypertension. Completed, enrolled 250 participants across 1 site.
Detailed Summary
The investigators are conducting an unblinded pilot randomized control trial of 250 persons living with HIV (PLWH), aged 18-65 years, who receive antiretroviral therapy care at Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), are virally suppressed, and have pre-hypertension (systolic blood pressure (SBP) 120-139 or diastolic blood pressure (DBP) 80-89 mmHg) to be randomized to early hypertension (HTN) treatment versus standard of care (SOC). Participants will be recruited from GHESKIO's HIV clinic. Eligible individuals will complete informed consent and be randomized to early HTN treatment vs. SOC. Participants in early HTN treatment will initiate amlodipine immediately versus those in SOC will initiate amlodipine only if they meet the HTN threshold (SBP ≥140 or DBP ≥90 mmHg) during the study period. All participants will be followed for 12 months.
Study Details
Timeline
Interventions
Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.