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

• Status: Recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborators: Aminu Kano Teaching Hospital; National Cancer Institute (NCI); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); SAIC-Frederick, Inc.
• Treatments: Lisinopril

Criteria

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 apart) of < 30 mg/g OR > 300 mg/g

• Relative symptomatic hypotension (BP <90/60)

• Currently receiving an ACEi and/or ARB; OR

• 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.)