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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV Tenofovir |
| ||
| HIV No tenofovir |
| ||
| Seronegative controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Free Water Clearance | Low sodium water overload | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Urine osmolarity | one month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with and without HIV infection followed at Hospital Italiano de Buenos Aires, university-affiliated tertiary-care community hospital
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| Name | Affiliation | Role |
|---|---|---|
| Waldo H Belloso, MD | Hospital Italiano de Buenos Aires | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires - Infectious Diseases Section | Buenos Aires | Buenos Aires F.D. | 1181 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21519246 | Background | Phair J, Palella F. Renal disease in HIV-infected individuals. Curr Opin HIV AIDS. 2011 Jul;6(4):285-9. doi: 10.1097/COH.0b013e3283476bc3. | |
| 21331321 | Background | Estrella MM, Fine DM, Atta MG. Recent developments in HIV-related kidney disease. HIV Ther. 2010 Sep;4(5):589-603. doi: 10.2217/hiv.10.42. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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|
| 17026723 | Background | Mathew G, Knaus SJ. Acquired Fanconi's syndrome associated with tenofovir therapy. J Gen Intern Med. 2006 Nov;21(11):C3-5. doi: 10.1111/j.1525-1497.2006.00518.x. |
| 21716719 | Background | Fernandez-Fernandez B, Montoya-Ferrer A, Sanz AB, Sanchez-Nino MD, Izquierdo MC, Poveda J, Sainz-Prestel V, Ortiz-Martin N, Parra-Rodriguez A, Selgas R, Ruiz-Ortega M, Egido J, Ortiz A. Tenofovir nephrotoxicity: 2011 update. AIDS Res Treat. 2011;2011:354908. doi: 10.1155/2011/354908. Epub 2011 Jun 7. |
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| 20100969 | Background | Choi AI, Li Y, Deeks SG, Grunfeld C, Volberding PA, Shlipak MG. Association between kidney function and albuminuria with cardiovascular events in HIV-infected persons. Circulation. 2010 Feb 9;121(5):651-8. doi: 10.1161/CIRCULATIONAHA.109.898585. Epub 2010 Jan 25. |
| 19578239 | Background | Gupta SK, Smurzynski M, Franceschini N, Bosch RJ, Szczech LA, Kalayjian RC; AIDS Clinical Trials Group Longitudinal Linked Randomized Trials Study Team. The effects of HIV type-1 viral suppression and non-viral factors on quantitative proteinuria in the highly active antiretroviral therapy era. Antivir Ther. 2009;14(4):543-9. |
| 22190152 | Background | Kalayjian RC. Kidney Disease in HIV-Infected Persons. Curr Infect Dis Rep. 2012 Feb;14(1):83-90. doi: 10.1007/s11908-011-0228-2. |
| 21643783 | Background | Kalayjian RC. Renal issues in HIV infection. Curr HIV/AIDS Rep. 2011 Sep;8(3):164-71. doi: 10.1007/s11904-011-0080-x. |
| 18838746 | Background | Szczech LA. Renal dysfunction and tenofovir toxicity in HIV-infected patients. Top HIV Med. 2008 Oct-Nov;16(4):122-6. |
| 21857491 | Background | 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. |
| 19783343 | Background | Hall AM, Edwards SG, Lapsley M, Connolly JO, Chetty K, O'Farrell S, Unwin RJ, Williams IG. Subclinical tubular injury in HIV-infected individuals on antiretroviral therapy: a cross-sectional analysis. Am J Kidney Dis. 2009 Dec;54(6):1034-42. doi: 10.1053/j.ajkd.2009.07.012. Epub 2009 Sep 23. |
| 19262355 | Background | Labarga P, Barreiro P, Martin-Carbonero L, Rodriguez-Novoa S, Solera C, Medrano J, Rivas P, Albalater M, Blanco F, Moreno V, Vispo E, Soriano V. Kidney tubular abnormalities in the absence of impaired glomerular function in HIV patients treated with tenofovir. AIDS. 2009 Mar 27;23(6):689-96. doi: 10.1097/QAD.0b013e3283262a64. |
| 4347364 | Background | Chaimovitz C, Levi J, Better OS, Oslander L, Benderli A. Studies on the site of renal salt loss in a patient with Bartter's syndrome. Pediatr Res. 1973 Feb;7(2):89-94. doi: 10.1203/00006450-197302000-00004. No abstract available. |
| 704989 | Background | Tabernero Romo JM, Rodriguez Commes JL, Macias Nunez JF, Bondia Roman A, Corbacho Becerra L, Juanes Gonzalez A, de Castro del Pozo S. [Free erythropoietic protoporphyrins in chronic renal insufficiency]. Rev Clin Esp. 1978 Jul;150(1-2):31-4. No abstract available. Spanish. |
| 21072593 | Background | Musso CG, Macias-Nunez JF. Dysfunction of the thick loop of Henle and senescence: from molecular biology to clinical geriatrics. Int Urol Nephrol. 2011 Mar;43(1):249-52. doi: 10.1007/s11255-010-9783-y. Epub 2010 Nov 12. |
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| 2299765 | Background | Vitting KE, Gardenswartz MH, Zabetakis PM, Tapper ML, Gleim GW, Agrawal M, Michelis MF. Frequency of hyponatremia and nonosmolar vasopressin release in the acquired immunodeficiency syndrome. JAMA. 1990 Feb 16;263(7):973-8. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052801 | Male Urogenital Diseases |