NCT04692467CompletedPhase 2
Treatment of Early Hypertension Among Persons Living With HIV in Haiti
Source: ClinicalTrials.gov · Last updated 9 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 250 (actual)
- First submitted
- 15 Dec 2020
- Start date
- 26 Feb 2021
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- HIV, High blood pressure
- NCT number
- NCT04692467
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 250
- From 26 Feb 2021 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On protease inhibitor/ritonavir
Other illness
- Kidney disease or diabetes
- Advanced illness with limited life expectancy
Other
- Pregnancy
- Plans to move out of the area within the next year
- Clinician determination that patient is unstable on ART
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GHESKIO Coordinator of this site? Confirm its status | Port-au-Prince | Haiti | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.