Phase 2 N=250 Randomized Treatment

Treatment of Early Hypertension Among Persons Living With HIV in Haiti

HIV/AIDS · Pre Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT04692467 ↗

Enrolled (actual)

250

Serious AEs

0.4%

Results posted

Apr 2024

Primary outcome: Primary: Change in Mean Systolic Blood Pressure (SBP) — -10.58; -4.65 mmHg — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Amlodipine 5mg (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Weill Medical College of Cornell University
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Systolic Blood Pressure (SBP)	-10.58; -4.65	<0.0001 sig
SECONDARY Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL	124; 126; 115; 114	—
SECONDARY Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls	107; 114; 98; 91; 111; 99	—
SECONDARY Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.	0; 0	—
SECONDARY Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.	0; 0	—
SECONDARY Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.	0; 0	—
SECONDARY Adverse Events	3; 0	—
SECONDARY Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.	0; 0	—
SECONDARY Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.	0; 0	—
SECONDARY Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.	0; 0	—
SECONDARY Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.	0; 0	—
SECONDARY Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months	122; 120	—
SECONDARY Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers	8; 2; 12; 2; 10; 2	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04692467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.