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

NCT01869010 | Completed

• 1 other identifier: 1237
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

HIV Infection

Keywords

HIV infection; Antiretroviral treatment; Renal disease; Renal tubular damage; Free-water clearance

Outcome Measures

Primary Outcomes (1)

• Free Water Clearance

  Low sodium water overload

  1 month

Secondary Outcomes (1)

• Urine osmolarity

  one month

Study Arms (3)

HIV Tenofovir

Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls

HIV No tenofovir

Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls

Seronegative controls

Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls

Interventions

Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls OTHER

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 No tenofovir; HIV Tenofovir; Seronegative controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires - Infectious Diseases Section

Buenos Aires, Buenos Aires F.D., 1181, Argentina

Location

Related Publications (22)

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MeSH Terms

Conditions

HIV Infections; Kidney Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Waldo H Belloso, MD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 5, 2013
• Study Start: January 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 9, 2025

Record last verified: 2018-02

Locations

AR (1)