CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controlsother
Likely dose
Not stated in record
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Search/NCT01869010
NCT01869010N/ACompleted

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

Hospital Italiano de Buenos Aires·observational·Posted Jun 5, 2013·Updated Sep 9, 2025

In Brief

An observational study evaluating Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls for HIV Infection. Completed, enrolled 30 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesArgentina
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2013
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.1 years ago

Interventions

Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controlsother

This test is based on the exploration of the tubular response to an acute fluid load. After overnight fast, all participants received twenty cc/Kg of mineralized water per os and two liters of intravenous hypotonic solution (0.66%) infused in two hours. Three blood samples are drawn (at 0, 60 and 120 minutes) and also urine samples are collected from each person at baseline and at 30 (±5) minutes intervals during the whole test. From the obtained blood and urine samples creatinine and osmolarity are measured, and then from the data corresponding to the most hypotonic urine sample (maximum dilution) and its corresponding blood sample three renal physiological parameters (proximal sodium clearance, free water clearance, sodium TALH reabsorption) are analyzed. Since patient inclusion follow up period is one month