Trial Outcomes & Findings for Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria (NCT NCT03201939)

NCT ID: NCT03201939

Last Updated: 2025-06-26

Results Overview

Proportion of study participants regressing from microalbuminuria (uACR 30-300) to normoalbuminuria (uACR \< 30 mg/g) by study arm

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 66 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2025-06-26

Participant Flow

66 participants were enrolled from 4/1/2021 thru 7/22/2021, with all participants being followed intensively through 11/20/2021, at which time, per DSMB recommendations, the study was paused (for reasons related to laboratory quality control (QC), specifically, the inability to accurately measure urine albumin on-site). All involved IRBs were notified and all participants were given a "Dear Participant" letter. Reasons for study pause were not at all related to any safety concerns.

Participant milestones

Measure	Placebo Comparator (Control Arm) Matched placebo	Active Medication (Intervention Arm) ACE-inhibitor lisinopril
Overall Study STARTED	32	34
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	32	34

Reasons for withdrawal

Measure	Placebo Comparator (Control Arm) Matched placebo	Active Medication (Intervention Arm) ACE-inhibitor lisinopril
Overall Study Study was suspended by DSMB because of laboratory quality control issues.	32	34

Baseline Characteristics

Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria

Baseline characteristics by cohort

Measure	Active Medication (Intervention Arm) n=34 Participants ACE-inhibitor lisinopril Lisinopril: ACE-inhibitor (lisinopril)(intervention arm	Placebo Comparator (Control Arm) n=32 Participants Matched placebo Placebo Oral Tablet: Comparator placebo (control arm)	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	41 years STANDARD_DEVIATION 7 • n=5 Participants	42 years STANDARD_DEVIATION 6 • n=7 Participants	42 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 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	34 Participants n=5 Participants	32 Participants n=7 Participants	66 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 Nigeria	34 participants n=5 Participants	32 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The data at 2 years was not collected since the study terminated prior to 2 years.

Proportion of study participants regressing from microalbuminuria (uACR 30-300) to normoalbuminuria (uACR < 30 mg/g) by study arm

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Population: The data at 2 years was not collected since the study terminated prior to 2 years.

Proportion of study participants progressing from microalbuminuria (uACR 30-300) to macroalbuminuria (uACR > 300 mg/g) by study arm

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 2 years

Population: The data at 2 years was not collected since the study terminated prior to 2 years.

Mean change in urinary albumin to creatinine ratio (uACR) among study participants at study timepoints by study arm

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: The data at 2 years was not collected since the study terminated prior to 2 years.

Worsening renal function (as measured by serum creatinine)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Mortality (All-cause) by study arm

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Proportion with 40% decline in eGFR (measured using CKD-EPI-Cr-CyC equation)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Mean change in eGFR (measured using CKD-EPI-Cr-CyC equation)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 year, 2 years

WHOQOL-HIV scale evaluates quality of life based on physical, psychological, social, environmental, and spiritual domains, as well as level of independence. We will use the 31-question version, with each question rated on a 5-point Likert scale. Scores of questions within each domain are averaged to get domain score, and final score is mean of domain scores multiplied by 4. Final score ranges from 4 to 20, with 20 being optimal.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 year, 2 years

Karnofsky Performance Score measures change in clinical/performance status with values ranging from 0 to 100, where 100 is perfect health and 0 is death.

Outcome measures

Outcome data not reported

Adverse Events

Placebo Comparator (Control Arm)

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Active Medication (Intervention Arm)

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Comparator (Control Arm) n=32 participants at risk Placebo comparator (Control arm) -- matched placebo	Active Medication (Intervention Arm) n=34 participants at risk Active study medication -- ACE-inhibitor lisinopril
Vascular disorders Angioedema	0.00% 0/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	2.9% 1/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Renal and urinary disorders Worsening Kidney Function, decrease in eGFR and/or uACR	9.4% 3/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	11.8% 4/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.

Other adverse events

Measure	Placebo Comparator (Control Arm) n=32 participants at risk Placebo comparator (Control arm) -- matched placebo	Active Medication (Intervention Arm) n=34 participants at risk Active study medication -- ACE-inhibitor lisinopril
Cardiac disorders Hypotension	6.2% 2/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	11.8% 4/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 2/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	8.8% 3/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
General disorders Dizziness	0.00% 0/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	5.9% 2/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Investigations Hyperkalemia	0.00% 0/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	2.9% 1/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
General disorders Headache	3.1% 1/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	0.00% 0/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Ear and labyrinth disorders Tinnitus	0.00% 0/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	2.9% 1/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Cardiac disorders Hypertension	12.5% 4/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	5.9% 2/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
General disorders Fever	0.00% 0/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	11.8% 4/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Gastrointestinal disorders Diarrhoea	0.00% 0/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	2.9% 1/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Gastrointestinal disorders Emesis	3.1% 1/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	0.00% 0/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Gastrointestinal disorders Abdominal Pain	3.1% 1/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	0.00% 0/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
General disorders Upper/Lower Limb Pain	0.00% 0/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	5.9% 2/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.
Investigations Hypokalemia	0.00% 0/32 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.	2.9% 1/34 • AE data was collected over 7 months; NOTE: AE data planned to be collected among all study participants for the full 2 years of study follow-up, but study was suspended early due to identified laboratory quality issues (per DSMB) and once these lab QA/QC issues were rectified, there was insufficient time to follow all study participants for full, specified duration of follow-up; therefore the study was terminated.

Additional Information

C. William Wester

Vanderbilt University Medical Center

Phone: 6158750145

Email: william.wester@vumc.org

Results disclosure agreements

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