Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria (NCT03201939) | Clinical Trial Compass
TerminatedPhase 2
Optimal Management of HIV Infected Adults at Risk for Kidney Complications in Nigeria
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.
Nigeria66 participantsStarted 2021-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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
Exclusion criteria:
* Pregnant or currently breastfeeding
* eGFR of \<60 ml/min/1.73m2 (using CKD-EPI-Cr-CyC equation)
* 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
* Known history of Diabetes diabetes mellitus (would qualify for treatment with an ACEi/ARB)
* Poorly controlled hypertension (≥3 BP readings \>160/110 in past 3 6 months)
* Known history of Congestive congestive heart failure (chronic)
* Average uACR (calculated on values obtained from 2 successive measures 4-8 weeks…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Regression From Microalbuminuria (uACR 30-300) to Normoalbuminuria (uACR < 30 mg/g) by Study Arm
Timeframe: 2 years
2
Progression From Microalbuminuria (uACR 30-300) to Macroalbuminuria (uACR > 300 mg/g) by Study Arm
Timeframe: 2 years
3
Mean Change in Urinary Albumin to Creatinine Ratio (uACR)