Treatment of Early Hypertension Among Persons Living With HIV in Haiti

NCT04692467 | Completed Phase 2 Results DMC

• 2 other identifiers: 20-03021735R21TW011693
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS; Pre Hypertension

Keywords

hypertension; HIV

Outcome Measures

Primary Outcomes (1)

• Change in Mean Systolic Blood Pressure (SBP)

  Baseline, 12 months

Secondary Outcomes (12)

• Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL

  Baseline, 12 months

• Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls

  Baseline, 6 months and 12 months

• Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.

  Followup month 1

• Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.

  Followup month 2

• Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.

  Followup month 3

Study Arms (2)

Intervention (Early hypertension)

EXPERIMENTAL

Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP \>130 mmHg after 1 month.

Drug: Amlodipine 5mg

Standard of Care

NO INTERVENTION

Participants randomized to the SOC arm will not be initiated on any medications initially. They may be initiated on amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).

Interventions

Amlodipine 5mg DRUG

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

Also known as: Norvasc

Intervention (Early hypertension)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

GHESKIO

Port-au-Prince, Haiti

Location

Related Publications (2)

• Yan LD, Rouzier V, Sufra R, Sauveur RS, Guiteau C, Lee MH, Ogyu A, Mourra N, Oparil S, Theard M, Brisma JP, Alfred JP, Deschamps MD, Pape JW, McNairy ML. Treatment of prehypertension among adults with HIV. AIDS. 2025 Mar 1;39(3):261-269. doi: 10.1097/QAD.0000000000004065. Epub 2024 Nov 13.

  PMID: 39761592 DERIVED

• Yan LD, Rouzier V, Dade E, Guiteau C, Pierre JL, St-Preux S, Metz M, Oparil S, Pape JW, McNairy M. Treatment of early hypertension among persons living with HIV in Haiti: Protocol for a randomized controlled trial. PLoS One. 2021 Aug 5;16(8):e0254740. doi: 10.1371/journal.pone.0254740. eCollection 2021.

  PMID: 34351939 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Prehypertension; Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Margaret McNairy
• Organization: Weill Cornell Medicine

mam9365@med.cornell.edu

646-962-8140

Study Officials

• Margaret McNairy, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Jean Pape

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 31, 2020
• Study Start: February 26, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 9, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and statistical analysis plan available after publication and ending 3 years following publication.
• Access Criteria: Researchers who provide a methodologically sound proposal may have access. Proposals should be directed to the PI at mam9365@med.cornell.edu. To gain access, data requestors will need to sign a data access agreement. Data are available following publications through 3 years after publication and will be provided directly from the PI.

Locations

HA (1)