A Phase 2 interventional study of Amlodipine 5mg in HIV/AIDS and Pre Hypertension, sponsored by Weill Medical College of Cornell University. Completed at 1 site in Haiti. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Weill Medical College of Cornell University · Phase 2, Interventional, and Treatment
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.
The investigators propose a pilot randomized controlled trial to evaluate antihypertensive treatment among people living with HIV (PLWH) with pre-hypertension (pre-HTN) at GHESKIO. This study will provide critical data on the feasibility, benefits and risks of antihypertensive treatment for cardiovascular disease (CVD) prevention among PLWH with pre-HTN that will inform a future definitive trial powered for incident CVD events.
For the pilot study, the investigators will enroll 250 PLWH (18-65 years of age) who have been on antiretroviral therapy (ART) for ≥ 1 years with viral suppression within past 12 months and SBP 120-139 or DBP 80-89 mm Hg and no current antihypertensive treatment; randomize them to "early HTN treatment" or the current standard of care (SOC); and follow them for 12 months. Amlodipine is the recommended first-line anti-hypertensive medication according to Haiti's new primary care HTN guidelines. Participants in the early HTN treatment arm will initiate amlodipine 5 mg immediately, increasing to 10 mg if SBP >130 mm Hg after 1 month. Participants in the SOC arm will initiate amlodipine only if they develop HTN (SBP ≥140 or DBP ≥90 mm Hg).
Participants that meet study eligibility criteria will proceed to study enrollment visit (\~90 min). Participants will be randomized to early HTN treatment vs. SOC in a 1:1 ratio using a computer-generated random assignment. The research nurse will collect demographic and clinical data, administer a baseline questionnaire, measure unobserved BP, and perform an ECG. The questionnaire includes a CVD medical history, family history, medications, CVD health behaviors (smoking, alcohol, physical activity, and diet) using validated questions that have been used at GHESKIO and are comparable to those used in US cohorts. Enrollment labs (\~15ml of venous blood) including HgbA1c, total cholesterol, high density cholesterol, CD4 (cluster of differentiation 4) cell count, and HIV viral load (unless available from electronic medical record in the past 6 months) will be collected. Samples of serum and plasma will be stored for future studies, with documented consent from participants. The study physician will interpret the ECG and perform an echocardiogram and vascular ultrasound.
Study drug will be dispensed to participants randomized to the early treatment arm with appropriate education and counseling on adherence and potential side effects. Amlodipine will be started at 5mg at enrollment and increased to 10mg if SBP >130 mm Hg after 1 month for participants in the early treatment arm. Locator and contact information will be verified and follow up appointment given.
After enrollment and randomization assignment (including amlodipine initiation), participants will have follow-up visits either at GHESKIO (months 0.5-1, 3, 6, 9, 12) or in the community / home with community health workers (months 2, 5, 8). All visits will include BP measurement, lifestyle counseling, adherence encouragement, and assessment of adverse events. The GHESKIO visits will also include a physical exam. Participants in the early intervention arm will receive monthly amlodipine refills. Participants in the SOC arm will initiate amlodipine only if they develop hypertension (SBP >140 or DBP >90 mm Hg).
At the 12-month study visit, participants will also complete a brief questionnaire about changes in health behaviors and have viral load measured. Participants may return to the HIV clinic at any time for symptoms, questions, or other concerns, and a BP measurement will be taken at each of these encounters. Adverse events will be assessed at each visit. Medical record abstraction will be done by research staff for any hospitalization or death among a participant.
Exclusion Criteria:
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
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).
Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.
Also known as: Norvasc
Change in Mean Systolic Blood Pressure (SBP)
Time frame: Baseline, 12 months
Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL
Time frame: Baseline, 12 months
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls
Time frame: 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.
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
Time frame: 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.
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
Time frame: 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.
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
Time frame: Followup month 3
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.
Time frame: Followup month 5
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.
Time frame: Followup month 6
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.
Time frame: Followup month 8
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.
Time frame: Followup month 9
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.
Time frame: Followup month 12
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).
Time frame: Baseline, 12 months
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).
Time frame: 12 months
| Milestone | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Started | 124 | 126 |
| Completed | 124 | 126 |
| Not completed | 0 | 0 |
| mmHg | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Change in Mean Systolic Blood Pressure (SBP) | -10.58 ± 11.01 | -4.65 ± 11.41 |
| participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Baseline | 124 | 126 |
| 12 months | 115 | 114 |
| participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Baseline | 107 | 114 |
| 6 months | 98 | 91 |
| 12 months | 111 | 99 |
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related. | 10 | 0 |
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related. | 8 | 0 |
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| 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 |
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.
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Adverse Events | 3 | 0 |
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related. | 2 | 0 |
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related. | 1 | 0 |
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| 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 |
Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| 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 |
All participants were included in enrolment. Remaining in the study was defined as having a clinic visit at month 12 (final study visit).
| Participants | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months | 122 | 120 |
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).
| participants | Intervention (Early Hypertension) | Providers |
|---|---|---|
| Satisfaction | 8 | 2 |
| Positive Effects | 12 | 2 |
| Negative Effects | 10 | 2 |
| Intent to continue | 11 | 0 |
| Amlodipine Initiation | 3 | 2 |
| CVD Risk | 10 | 2 |
| Unintended consequences | 0 | 2 |
| Implementation Challenges | 6 | 2 |
Collected over All participants were asked at each community and clinic visit whether they had adverse events. Clinic visits occurred at 1, 3, 6, 9, and 12 months after enrolment. Community visits occurred at 2, 5, and 8 months after enrolment. Participants were followed up for up to 12 months after enrollment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention (Early Hypertension) | 0/124 (0%) | 1/124 (0.8%) | 22/124 (17.7%) |
| Standard of Care | 2/126 (1.6%) | 0/126 (0%) | 0/126 (0%) |
| Event | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| Marked weaknessGeneral disorders | 1/124 | 0/126 |
| Event | Intervention (Early Hypertension) | Standard of Care |
|---|---|---|
| DizzinessCardiac disorders | 12/124 | 0/126 |
| EdemaCardiac disorders | 4/124 | 0/126 |
| Urine Flow IncreaseRenal and urinary disorders | 2/124 | 0/126 |
| EdemaCardiac disorders | 1/124 | 0/126 |
| FatigueCardiac disorders | 1/124 | 0/126 |
| HeadacheCardiac disorders | 1/124 | 0/126 |
| DizzinessCardiac disorders | 1/124 | 0/126 |
| Neck StiffnessMusculoskeletal and connective tissue disorders | 1/124 | 0/126 |
In intention-to-treat analysis, the analysis population is the same as the assignment under randomization.
| Age, Continuous(years) | Intervention (Early Hypertension) | Standard of Care | Total |
|---|---|---|---|
| Median | 50.0 (48.3 to 55.3) | 47.5 (41.3 to 55.0) | 49.0 (42.0 to 55.0) |
| Sex: Female, Male(Participants) | Intervention (Early Hypertension) | Standard of Care | Total |
|---|---|---|---|
| Female | 48 | 54 | 102 |
| Male | 76 | 72 | 148 |
| Ethnicity (NIH/OMB)(Participants) | Intervention (Early Hypertension) | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 124 | 126 | 250 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention (Early Hypertension) | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 124 | 126 | 250 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention (Early Hypertension) | Standard of Care | Total |
|---|---|---|---|
| Haiti | 124 | 126 | 250 |
| Systolic Blood Pressure(mmHg) | Intervention (Early Hypertension) | Standard of Care | Total |
|---|---|---|---|
| Median | 129 (126 to 132) | 128 (126 to 133) | 129 (126 to 132) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All the individual participant data collected during the trial, after deidentification will be shared.
Supporting information: Study protocol, Sap
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Weill Medical College of Cornell University