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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869010
• Other study ID #: HIBA 1237
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: February 21, 2018
• Start date: January 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2018
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires - Infectious Diseases Section	Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (22)

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Vrouenraets SM, Fux CA, Wit FW, Garcia EF, Furrer H, Brinkman K, Hoek FJ, Abeling NG, Krediet RT, Reiss P; Prepare Study Group. Persistent decline in estimated but not measured glomerular filtration rate on tenofovir may reflect tubular rather than glomerular toxicity. AIDS. 2011 Nov 13;25(17):2149-55. doi: 10.1097/QAD.0b013e32834bba87. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free Water Clearance	Low sodium water overload	1 month
Secondary	Urine osmolarity		one month