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Treatment of Early Hypertension Among Persons Living With HIV in Haiti

NCT04692467 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2024-04-09

Study results available
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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.

Conditions

Interventions

DRUG

Amlodipine 5mg

Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.

Sponsors & Collaborators

  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

    collaborator OTHER

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Margaret McNairy, MD · Weill Medical College of Cornell University

  • Jean Pape · Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2023-06-30
Completion
2023-12-30

Countries

  • Haiti

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04692467 on ClinicalTrials.gov