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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Waldo H. Belloso, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01869010
First received: May 29, 2013
Last updated: May 31, 2013
Last verified: May 2013

May 29, 2013
May 31, 2013
January 2010
March 2012   (final data collection date for primary outcome measure)
Free Water Clearance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Low sodium water overload
Same as current
Complete list of historical versions of study NCT01869010 on ClinicalTrials.gov Archive Site
Urine osmolarity [ Time Frame: one month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection
Not Provided

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with and without HIV infection followed at Hospital Italiano de Buenos Aires, university-affiliated tertiary-care community hospital

HIV Infection
Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls
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
  • HIV Tenofovir
    Intervention: Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls
  • HIV No tenofovir
    Intervention: Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls
  • Seronegative controls
    Intervention: Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2012
March 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01869010
HIBA 1237
No
Waldo H. Belloso, Hospital Italiano de Buenos Aires
Hospital Italiano de Buenos Aires
Not Provided
Principal Investigator: Waldo H Belloso, MD Hospital Italiano de Buenos Aires
Hospital Italiano de Buenos Aires
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP