Treatment of Early Hypertension Among Persons Living With HIV in Haiti

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

• PLWH 18-65 years of age

• ART duration ≥ 1 year, stable regimen ≥ 6 months

• HIV 1-RNA < 1,000 copies/mL within past 12 months

• Pre-HTN (SBP 120-139 or DBP 80-89 mm Hg)

• No current antihypertensive treatment

• Receives HIV care at GHESKIO

• Willing to provide consent

Exclusion Criteria:

• Pregnancy

• Kidney disease or diabetes

• On protease inhibitor/ritonavir

• Advanced illness with limited life expectancy

• Plans to move out of the area within the next year

• Clinician determination that patient is unstable on ART