Trial Outcomes & Findings for Treatment of Early Hypertension Among Persons Living With HIV in Haiti (NCT NCT04692467)

NCT ID: NCT04692467

Last Updated: 2024-04-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 250 participants
• Primary outcome timeframe: Baseline, 12 months
• Results posted on: 2024-04-09

Participant Flow

Participant milestones

Measure	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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	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).
Overall Study STARTED	124	126
Overall Study COMPLETED	124	126
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Early Hypertension Among Persons Living With HIV in Haiti

Baseline characteristics by cohort

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).	Total n=250 Participants Total of all reporting groups
Age, Continuous	50.0 years n=5 Participants	47.5 years n=7 Participants	49.0 years n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	54 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	72 Participants n=7 Participants	148 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	124 Participants n=5 Participants	126 Participants n=7 Participants	250 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	124 Participants n=5 Participants	126 Participants n=7 Participants	250 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Haiti	124 participants n=5 Participants	126 participants n=7 Participants	250 participants n=5 Participants
Systolic Blood Pressure	129 mmHg n=5 Participants	128 mmHg n=7 Participants	129 mmHg n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 months

Population: 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.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
Change in Mean Systolic Blood Pressure (SBP)	-10.58 mmHg Standard Deviation 11.01	-4.65 mmHg Standard Deviation 11.41

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: 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.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL Baseline	124 participants	126 participants
Change in Number of Participants With HIV Viral Suppression as Measured by HIV-1 RNA Viral Loads < 1,000 Copies/mL 12 months	115 participants	114 participants

SECONDARY outcome

Timeframe: Baseline, 6 months and 12 months

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls Baseline	107 participants	114 participants
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls 6 months	98 participants	91 participants
Change in HIV Medication Adherence as Measured by Number of Participants With > 90% Adherence Using 4-day Pill Recalls 12 months	111 participants	99 participants

SECONDARY outcome

Timeframe: Followup month 1

Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
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 Participants	0 Participants

SECONDARY outcome

Timeframe: Followup month 2

Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
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 Participants	0 Participants

SECONDARY outcome

Timeframe: Followup month 3

Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
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 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
Adverse Events	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Followup month 6

Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
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 Participants	0 Participants

SECONDARY outcome

Timeframe: Followup month 8

Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 Participants 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).
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 Participants	0 Participants

SECONDARY outcome

Timeframe: Followup month 9

Population: 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.

Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=125 Participants 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).
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 Participants	0 Participants

SECONDARY outcome

Timeframe: Followup month 12

Population: 2 participants in the standard of care arm were excluded from analysis because these participants died of causes unrelated to the research prior to follow-up month 12.

Symptoms will be categorized according to the Division of AIDS (DAIDS) severity score, with Grade III-IV considered adverse events.

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=124 Participants 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).
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 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 12 months

Population: 2 participants in the standard of care arm were excluded from analysis because these participants died of causes unrelated to the research prior to follow-up month 12.

All participants were included in enrolment. Remaining in the study was defined as having a clinic visit at month 12 (final study visit).

Outcome measures

Measure	Intervention (Early Hypertension) n=124 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=124 Participants 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).
Number of Participants Who Are Enrolled at Baseline and Remain in the Study by 12 Months	122 Participants	120 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Focus-group discussions were conducted with participants who received the intervention. A subset of 16 participants were randomly selected and called to conduct FGD. Individual interviews were conducted with providers. All physicians (two) who were involved in the study were interviewed. One nurse was excluded as they could not be contacted as they had left the clinic.

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).

Outcome measures

Measure	Intervention (Early Hypertension) n=16 Participants 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=2 Participants 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).
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers Satisfaction	8 participants	2 participants
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers Positive Effects	12 participants	2 participants
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers Negative Effects	10 participants	2 participants
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers Intent to continue	11 participants	0 participants
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers Amlodipine Initiation	3 participants	2 participants
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers CVD Risk	10 participants	2 participants
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers Unintended consequences	0 participants	2 participants
Acceptability of Study Intervention Assessed by Qualitative Interviews Among Participants and Providers Implementation Challenges	6 participants	2 participants

Adverse Events

Intervention (Early Hypertension)

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Measure	Intervention (Early Hypertension) n=124 participants at risk 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 participants at risk 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).
General disorders Marked weakness	0.81% 1/124 • Number of events 1 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.	0.00% 0/126 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.

Other adverse events

Measure	Intervention (Early Hypertension) n=124 participants at risk 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. Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.	Standard of Care n=126 participants at risk 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).
Cardiac disorders Edema	0.81% 1/124 • Number of events 1 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.	0.00% 0/126 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.
Cardiac disorders Fatigue	0.81% 1/124 • Number of events 1 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.	0.00% 0/126 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.
Cardiac disorders Headache	0.81% 1/124 • Number of events 1 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.	0.00% 0/126 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.
Cardiac disorders Dizziness	0.81% 1/124 • Number of events 1 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.	0.00% 0/126 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.
Renal and urinary disorders Urine Flow Increase	1.6% 2/124 • Number of events 2 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.	0.00% 0/126 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.
Musculoskeletal and connective tissue disorders Neck Stiffness	0.81% 1/124 • Number of events 1 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.	0.00% 0/126 • 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. Signs and symptoms of hypotension and peripheral edema, or any other reported side effects were graded using the existing Division of AIDS (DAIDS) criteria.

Additional Information

Dr. Margaret McNairy

Weill Cornell Medicine

Phone: 646-962-8140

Email: mam9365@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place