ClinicalTrials.gg
Sign In
CompletedNCT04692467Updated Apr 9, 2024Results posted

Treatment of Early Hypertension Among Persons Living With HIV in Haiti

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

Phase
Phase 2
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • HIV/AIDS
  • Pre Hypertension

Keywords

  • hypertension
  • HIV
03

In context

Acquired Immunodeficiency Syndrome

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

This study's enrollment of 250 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • PLWH 18-65 years of age
  • ART duration ≥ 1 year, stable regimen ≥ 6 months
  • 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

Exclusion Criteria:

  • Pregnancy
  • Kidney disease or diabetes
  • On protease inhibitor/ritonavir
  • Advanced illness with limited
  • Plans to move out of the area within the next year
  • Clinician determination that patient is unstable on ART
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (actual)

Study arms

  • Experimental
    Intervention (Early hypertension)

    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

  • No intervention
    Standard of Care

    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

  • DrugAmlodipine 5mg

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

    Also known as: Norvasc

06

What researchers measure

Primary outcomes

  1. Change in Mean Systolic Blood Pressure (SBP)

    Time frame: Baseline, 12 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  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 3

  6. 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

  7. 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

  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 8

  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 9

  10. 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

  11. 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

  12. 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

07

Results

Posted Apr 9, 2024

Participant flow

Participant flow — Overall Study
MilestoneIntervention (Early Hypertension)Standard of Care
Started124126
Completed124126
Not completed00

Outcome measures

PrimaryChange in Mean Systolic Blood Pressure (SBP)
Time frame:
Baseline, 12 months
Reported as:
Mean · mmHg
Change in Mean Systolic Blood Pressure (SBP)
mmHgIntervention (Early Hypertension)Standard of Care
Change in Mean Systolic Blood Pressure (SBP)-10.58 ± 11.01-4.65 ± 11.41
Statistical analysis
  • Intervention (Early Hypertension) vs Standard of Care · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -5.88 · 95% CI -8.77 to -3.01The mean difference reflects the difference in mean change (i.e., mean change = 12 months minus baseline for each arm) between the intervention arm and SOC arm (direction = intervention arm minus SOC arm).
SecondaryChange 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
Reported as:
Number · participants
Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL
participantsIntervention (Early Hypertension)Standard of Care
Baseline124126
12 months115114
SecondaryChange 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
Reported as:
Number · participants
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls
participantsIntervention (Early Hypertension)Standard of Care
Baseline107114
6 months9891
12 months11199
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
ParticipantsIntervention (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.100
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
ParticipantsIntervention (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.80
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
ParticipantsIntervention (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.00
SecondaryAdverse 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
Reported as:
Count of participants · Participants
Adverse Events
ParticipantsIntervention (Early Hypertension)Standard of Care
Adverse Events30
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
ParticipantsIntervention (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.20
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
ParticipantsIntervention (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
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
ParticipantsIntervention (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.00
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Subjects Who Have Adverse Events Related to Amlodipine, Including Dizziness, Fainting, Lower Extremity Edema, and Any Other Symptoms Which May be Related.
ParticipantsIntervention (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.00
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months
ParticipantsIntervention (Early Hypertension)Standard of Care
Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months122120
SecondaryAcceptability 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
Reported as:
Number · participants
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers
participantsIntervention (Early Hypertension)Providers
Satisfaction82
Positive Effects122
Negative Effects102
Intent to continue110
Amlodipine Initiation32
CVD Risk102
Unintended consequences02
Implementation Challenges62

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention (Early Hypertension)0/124 (0%)1/124 (0.8%)22/124 (17.7%)
Standard of Care2/126 (1.6%)0/126 (0%)0/126 (0%)
Most frequent serious events
Most frequent serious events
EventIntervention (Early Hypertension)Standard of Care
Marked weaknessGeneral disorders1/1240/126
Most frequent other events
Most frequent other events
EventIntervention (Early Hypertension)Standard of Care
DizzinessCardiac disorders12/1240/126
EdemaCardiac disorders4/1240/126
Urine Flow IncreaseRenal and urinary disorders2/1240/126
EdemaCardiac disorders1/1240/126
FatigueCardiac disorders1/1240/126
HeadacheCardiac disorders1/1240/126
DizzinessCardiac disorders1/1240/126
Neck StiffnessMusculoskeletal and connective tissue disorders1/1240/126

Baseline characteristics

In intention-to-treat analysis, the analysis population is the same as the assignment under randomization.

Age, Continuous
Age, Continuous(years)Intervention (Early Hypertension)Standard of CareTotal
Median50.0 (48.3 to 55.3)47.5 (41.3 to 55.0)49.0 (42.0 to 55.0)
Sex: Female, Male
Sex: Female, Male(Participants)Intervention (Early Hypertension)Standard of CareTotal
Female4854102
Male7672148
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention (Early Hypertension)Standard of CareTotal
Hispanic or Latino000
Not Hispanic or Latino124126250
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention (Early Hypertension)Standard of CareTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American124126250
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Intervention (Early Hypertension)Standard of CareTotal
Haiti124126250
Systolic Blood Pressure
Systolic Blood Pressure(mmHg)Intervention (Early Hypertension)Standard of CareTotal
Median129 (126 to 132)128 (126 to 133)129 (126 to 132)
08

Study locations

1 site
  • GHESKIO
    Port-au-Prince, Haiti
09

References and documents

Publications

  • 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. PubMed 34351939 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — All the individual participant data collected during the trial, after deidentification will be shared.

Supporting information: Study protocol, Statistical analysis plan

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.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2021 to primary completion in Jun 2023, 28 months.

Results were first posted in Apr 2024, 9 months after primary completion.

Of 57 non-industry phase 2 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 65. This study's 28 months is below that.

Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 18 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2020
First posted
Dec 31, 2020
StartActual
Feb 26, 2021
Primary completionActual
Jun 30, 2023
CompletionActual
Dec 30, 2023
Results first posted
Apr 9, 2024
Last update
Apr 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04692467
Lead sponsor
Weill Medical College of Cornell University
Collaborators
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Fogarty International Center of the National Institute of Health
Responsible party
Sponsor
First posted
Dec 31, 2020
Start date
Feb 26, 2021
Primary completion
Jun 30, 2023
Completion
Dec 30, 2023
Results posted
Apr 9, 2024
Last update
Apr 9, 2024

Study contacts

Margaret McNairy, MD
principal investigator · Weill Medical College of Cornell University
Jean Pape
principal investigator · Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Amlodipine

Other studies in this condition

Acquired Immunodeficiency Syndrome →

Other studies from this sponsor

Weill Medical College of Cornell University →

Start the discussion