Optimal Management of HIV-Infected Adults at Risk for Kidney Complications in Nigeria (R3 Study)

Not Applicable

Recruiting

• Conditions: HIV/AIDS; Kidney Diseases, Albuminuria, Genetic Predisposition; Kidney Disease

• Registration Number: PACTR201711002808414
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-27
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Adult (18-70 years of age)
Documented positive HIV-1 ELISA
On ART for a minimum of 6 months, suppresses plasma viral load result (<20 copies/mL) with past six months
Average uACR between 30-300 mg/g (based on 2 uACRs [first morning voids], with the second obtained 4-8 weeks after first specimen)
Urine dipstick proteinuria analysis result <2.0
eGFR = > 60ml/min/1.73m2 (using CKD-EPI-Cr-CYC equation)
If female, non pregnant (documentation of negative urine pregnancy test ) and not breastfeeding/lactating

Exclusion Criteria

•K+ >5.0 meEq/L or reasons to be concerned about hyperkalemia
•Known history of diabetes mellitus (would qualify for treatment with an ACEi/ARB)
•Poorly controlled hypertension (=3 BP readings >160/110 in past 6 months)
•Known history of 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;
•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 history of poor compliance (i.e. multiple missed scheduled clinic appointments, etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified