Trial · NCT04692467

Treatment of Early Hypertension Among Persons Living With HIV in Haiti

NCT04692467, Phase 2, Completed, Weill Medical College of Cornell University; results first posted 2024-04-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Early Hypertension Among Persons Living With HIV in Haiti. Trials, record NCT04692467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04692467

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment of Early Hypertension Among Persons Living With HIV in Haiti
NCT number: NCT04692467
Status: Completed
Phases: Phase 2
Enrollment: 250 participants, actual
Lead sponsor: Weill Medical College of Cornell University
Conditions: HIV/AIDS, Pre Hypertension
Interventions: Amlodipine 5mg
First posted: 2020-12-31
Last updated: 2024-04-09
Results first posted: 2024-04-09

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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.	Followup month 1	Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
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.	Followup month 2	Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
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.	Followup month 3	Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
Secondary	Adverse Events	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.
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.	Followup month 6	Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
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.	Followup month 8	Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.
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.	Followup month 9	Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Mean Systolic Blood Pressure (SBP)	Baseline, 12 months	For participants receiving Standard of Care, 120 of the 126 (95.2%) had a 12-month visit. For the participants receiving the intervention, 122 of the 124 (98.4%) had a 12-month visit.	mmHg	MEAN
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	At the 12-month visit, 8 participants in the Standard of Care arm and 5 participants in the intervention arm were missing viral load data.	participants	NUMBER
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		participants	NUMBER
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.	Followup month 1		Participants	COUNT_OF_PARTICIPANTS
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.	Followup month 2		Participants	COUNT_OF_PARTICIPANTS
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.	Followup month 3		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adverse Events	Followup month 5		Participants	COUNT_OF_PARTICIPANTS
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.	Followup month 6		Participants	COUNT_OF_PARTICIPANTS
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.	Followup month 8		Participants	COUNT_OF_PARTICIPANTS
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.	Followup month 9	1 participant in the standard of care arm was excluded from analysis because the participant died of causes unrelated to the research prior to follow-up month 9.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Mean Systolic Blood Pressure (SBP)	Intervention (Early Hypertension)		-10.58	Standard Deviation 11.01	mmHg
Change in Mean Systolic Blood Pressure (SBP)	Standard of Care		-4.65	Standard Deviation 11.41	mmHg
Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL	Intervention (Early Hypertension)	Baseline	124		participants
Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL	Standard of Care	Baseline	126		participants
Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL	Intervention (Early Hypertension)	12 months	115		participants
Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL	Standard of Care	12 months	114		participants
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls	Intervention (Early Hypertension)	Baseline	107		participants
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls	Standard of Care	Baseline	114		participants
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls	Intervention (Early Hypertension)	6 months	98		participants
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls	Standard of Care	6 months	91		participants

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intervention (Early Hypertension)	124
Overall Study	STARTED	Standard of Care	126
Overall Study	COMPLETED	Intervention (Early Hypertension)	124
Overall Study	COMPLETED	Standard of Care	126
Overall Study	NOT COMPLETED	Intervention (Early Hypertension)	0
Overall Study	NOT COMPLETED	Standard of Care	0

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Edema	Cardiac disorders	Intervention (Early Hypertension)	4	124	4
other	Edema	Cardiac disorders	Standard of Care	0	126	0
other	Edema	Cardiac disorders	Intervention (Early Hypertension)	1	124	1
other	Edema	Cardiac disorders	Standard of Care	0	126	0
other	Fatigue	Cardiac disorders	Intervention (Early Hypertension)	1	124	1
other	Fatigue	Cardiac disorders	Standard of Care	0	126	0
other	Headache	Cardiac disorders	Intervention (Early Hypertension)	1	124	1
other	Headache	Cardiac disorders	Standard of Care	0	126	0
other	Dizziness	Cardiac disorders	Intervention (Early Hypertension)	12	124	12
other	Dizziness	Cardiac disorders	Standard of Care	0	126	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intervention (Early Hypertension)	0	124
Total, all-cause mortality	Standard of Care	2	126
Total, other adverse events	Intervention (Early Hypertension)	22	124
Total, other adverse events	Standard of Care	0	126
Total, serious adverse events	Intervention (Early Hypertension)	1	124
Total, serious adverse events	Standard of Care	0	126

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34351939	DERIVED	PubMed
39761592	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21TW011693	Treatment of early hypertension in persons living with HIV for cardiovascular disease prevention in Haiti	MCNAIRY, MARGARET LEIGHTON	WEILL MEDICAL COLL OF CORNELL UNIV	FOGARTY INTERNATIONAL CENTER	2020 to 2021

Source NIH RePORTER

Trial comparisons11

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention (Early Hypertension) vs 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.	Trial comparisons
Intervention (Early Hypertension) vs Standard of Care: Adverse Events	Trial comparisons
Intervention (Early Hypertension) vs 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.	Trial comparisons
Intervention (Early Hypertension) vs 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.	Trial comparisons
Intervention (Early Hypertension) vs Standard of Care: Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months	Trial comparisons
Intervention (Early Hypertension) vs 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.	Trial comparisons
Intervention (Early Hypertension) vs Standard of Care: deaths from any cause	Trial comparisons
Intervention (Early Hypertension) vs 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.	Trial comparisons
Intervention (Early Hypertension) vs 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.	Trial comparisons
Intervention (Early Hypertension) vs 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.	Trial comparisons

1 to 10 of 11

See all 11 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04692467

GET https://conductscience.org/api/trials/v1/NCT04692467/results?page=2

API reference For AI assistants