TerminatedPhase 2
Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria
Key facts
- Who runs it
- Vanderbilt University Medical Center
- Where
- Nigeria1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 66 people enrolled
- Started
- 1 Apr 2021
- Ended
- 1 Feb 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Lisinopril
- Placebo Oral Tablet
- Record updated
- 26 June 2025
- Why it stopped
- DSMB recommendations, laboratory quality control (QC) issues. All lab Q/C issues addressed; DSMB approved study re-opening, but due to length of time required to address lab QC issues, insufficient follow-up time was available to complete study.
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Participated in Study Aim 1
- 18-70 years of age
- HIV-positive (as documented by HIV-1 ELISA testing)
- On ART for a minimum of six (6) months AND having a suppressed plasma viral load result (< 20 copies/mL) within the past 6 months
- Average uACR between 30-300 mg/g (based on 2 uACRs [first morning voids], with the second obtained 4-8 weeks after the first specimen)(NOTE: All aim 1 screened patients having a uACR value > 300 mg/g will undergo urine dipstick analysis for aim 2 eligibility, and if their urine dipstick results reveals ≥ 2+ protein, then they will be considered ineligible (no additional uACR testing will be necessary to determine eligibility)
- eGFR = >60 ml/min/1.73m2 (using CKD-EPI-Cr-CyC equation) AND
- If female, non-pregnant (documentation of negative urine pregnancy test) and not breastfeeding/lactating
Who cannot take part
- Known history of Diabetes diabetes mellitus (would qualify for treatment with an ACEi/ARB)
- Currently receiving an ACEi and/or ARB; OR
- Poorly controlled hypertension (≥3 BP readings >160/110 in past 3 6 months)
- Known history of Congestive congestive heart failure (chronic)
- Lack of suitability as a study candidate (i.e. active substance use disorder, active use of potentially nephrotoxic medication(s) (i.e. traditional medicines, etc.) and/or consistent alcohol, drug, and/or traditional medication use, and/or history of poor compliance (i.e. multiple missed scheduled clinic appointments, etc.)
- eGFR of <60 ml/min/1.73m2 (using CKD-EPI-Cr-CyC equation)
- Pregnant or currently breastfeeding
- Average uACR > 300 mg/g (based on 2 uACRs [first morning voids], with the second obtained 4-8 weeks after the first specimen)
- K+ >5.0 meEq/L or reasons to be concerned about hyperkalemia
- Average uACR (calculated on values obtained from 2 successive measures 4-8 weeks apart) of < 30 mg/g OR > 300 mg/g
- Relative symptomatic hypotension (BP <90/60)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
In this study, the Investigators plan to determine the optimal means to prevent or slow the progression of kidney disease among genetically at-risk northern Nigerian HIV-infected adults. Based on data from studies of diabetic kidney disease that used medications that block the renin angiotensin aldosterone system (RAAS), we plan to evaluate whether or not RAAS inhibition (using a widely available medication that blocks RAAS) in HIV-infected adults produces similarly promising results.
The 2 groups in the trial
- Active Medication (Intervention arm)Existing treatment, for comparison
ACE-inhibitor lisinopril
Treatment: Lisinopril
- Placebo comparator (Control arm)Placebo, for comparison
Matched placebo
Treatment: Placebo Oral Tablet
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 26 June 2025