Treatment of Early Hypertension Among Persons Living With HIV in Haiti
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Fogarty International Center of the National Institute of Health Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic