HIV/AIDS Clinical Trial
Official title:
Treatment of Early Hypertension Among Persons Living With HIV in Haiti
Verified date | March 2024 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Completed |
Enrollment | 250 |
Est. completion date | December 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Haiti | GHESKIO | Port-au-Prince |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | Fogarty International Center of the National Institute of Health, Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic |
Haiti,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mean Systolic Blood Pressure (SBP) | Baseline, 12 months | ||
Secondary | Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL | Baseline, 12 months | ||
Secondary | 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 | ||
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. | Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events. | Followup month 1 | |
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. | Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events. | Followup month 2 | |
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. | Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events. | Followup month 3 | |
Secondary | Adverse Events | Number of subjects who have adverse events related to amlodipine, including dizziness, fainting, lower extremity edema, and any other symptoms which may be related. Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events. | Followup month 5 | |
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. | Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events. | Followup month 6 | |
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. | Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events. | Followup month 8 | |
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. | Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events. | Followup month 9 | |
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. | Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events. | Followup month 12 | |
Secondary | Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months | All participants were included in enrolment. Remaining in the study was defined as having a clinic visit at month 12 (final study visit). | Baseline, 12 months | |
Secondary | Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers | Using semi-structured interview guides exploring topics including acceptability, side effects, perceived benefit, and perceived cost, in depth interviews will be conducted with 15-20 study participants in the intervention arm, and all healthcare providers involved in the study (nurses, doctors, social workers). | 12 months |
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