Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection

Completed

• Conditions: HIV Infection
• Interventions: Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls

• Registration Number: NCT01869010
• Lead Sponsor: Hospital Italiano de Buenos Aires

Brief Summary

The objective of the present study is to analyze the overall tubular function, and in particular that from the proximal tubule and the thick ascending loop of Henle (TALH) in patients with HIV infection receiving or not tenofovir-containing antiretroviral treatment in comparison with seronegative controls, by applying a validated tubular physiological test known as "Low sodium infusion test".

Hypothesis is that patients with HIV infection and normal renal function will show subclinical tubular abnormalities compared with seronegative controls

Detailed Description

Renal disease is a well recognized complication among patients with HIV infection. Either viral infection itself and the use of some antiretroviral drugs contribute to this serious non AIDS-defining condition that may affect both the glomeruli and the renal tubules.

The thick ascending loop of Henle constitutes the main location for free-water clearance determining kidney´s ability to concentrate and dilute urine in a direct and indirect fashion, respectively.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-05
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Inclusion criteria are as follows: adult patients (≥18 years old) with confirmed chronic HIV-1 infection who agreed to provide written informed consent. Patients under antiretroviral treatment must had a stable regimen for over six months and undetectable (<50 copies/ml) viral load for at least three months. At study entry all selected patients were confirmed as having normal physical examination, routine clinical laboratory including urinalysis, as well as renal and cardiac ultrasound.

Exclusion Criteria

• Exclusion criteria include patients with acute HIV infection (< 6 months of disease), personal history of nephropathy, plasma creatinine ≥1.3 mg/dl, Glomerular filtration rate ≤60ml/min/1.73 m² (as determined by Modification of Diet in renal Disease formula), presence of glucosuria/proteinuria (measured in spot urine sample), prior heart failure, concurrent opportunistic infection, chronic active hepatitis B or C, and use of potentially nephrotoxic agents in the prior week before the test (e.g diuretics, angiotensin converting enzyme antagonists, Angiotensin II receptor antagonists or non-steroidal anti-inflammatory agents).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV Tenofovir	Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls	-
Seronegative controls	Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls	-
HIV No tenofovir	Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls	-

Primary Outcome Measures

Name	Time	Method
Free Water Clearance	1 month	Low sodium water overload

Secondary Outcome Measures

Name	Time	Method
Urine osmolarity	one month

Trial Locations

Locations (1)

Hospital Italiano de Buenos Aires - Infectious Diseases Section; 🇦🇷 Buenos Aires, Caba, Argentina