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Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00551655
First Posted: October 31, 2007
Last Update Posted: November 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
AIDS Arms Inc.
  Purpose
Tenofovir (TDF)-containing regimens may be associated with decreasing renal function in HIV-infected patients concurrently treated with boosted PI's and/or have co-morbid conditions including diabetes mellitus, hypertension, anemia, hepatitis B, and hepatitis C.

Condition Phase
Human Immunodeficiency Viruses Kidney Failure HIV Infections Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by AIDS Arms Inc.:

Enrollment: 684
Study Start Date: May 2007
Study Completion Date: September 2007
Detailed Description:

COL109413 is a Phase IV retrospective database study involving the review of medical records of approximately 850 HIV-infected patients treated at a single center (Peabody Health Clinic, Dallas, Texas) and followed for up to a 4-year period (2003-2006). Patients whose GFR decreased >25% from baseline (BL) will be identified and their disease and treatment characteristics will be compared to those of patients whose GFR did not change. GFR will be calculated by both the MDRD and the Cockcroft-Gault methods.

The following information will be noted: patient age, weight, gender, race/ethnicity, viral load, CD4 cell count, serum creatinine and other available laboratory data, start of HAART therapy (TDF - vs non-TDF-containing), changes in drug treatment, co-morbidities (hypertension, diabetes mellitus, anemia, hepatitis C virus or hepatitis B virus infection), drug treatment for co-morbidities and non-HIV-related illnesses, and adherence by prescription refill. The study endpoints will be: time from treatment initiation-to-event (GFR decrease >25% from BL) analysis between TDF-containing vs non-TDF-containing antiretroviral therapy; number of patients who convert from National Kidney Foundation-defined mild to moderate renal impairment or from moderate to severe renal impairment in the TDF vs non-TDF-treated patients; effect of co-morbidities and concomitant medications on time to GFR decrease >25% from BL.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

Inclusion Criteria:

  • HIV positive patients seen between 2003 and 2006

Exclusion Criteria:

  • Fewer than two laboratory results
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551655


Locations
United States, Texas
Peabody Health Center
Dallas, Texas, United States, 75215
Sponsors and Collaborators
AIDS Arms Inc.
GlaxoSmithKline
Investigators
Principal Investigator: Keith Rawlings, MD AIDS Arms Inc.
  More Information

Publications:
Röling J, Schmid H, Fischereder M, Draenert R, Goebel FD. HIV-associated renal diseases and highly active antiretroviral therapy-induced nephropathy. Clin Infect Dis. 2006 May 15;42(10):1488-95. Epub 2006 Apr 11. Review.
Izzedine H, Launay-Vacher V, Deray G. Antiviral drug-induced nephrotoxicity. Am J Kidney Dis. 2005 May;45(5):804-17. Review.
Ross MJ, Klotman PE. HIV-associated nephropathy. AIDS. 2004 May 21;18(8):1089-99.
Guo X, Nzerue C. How to prevent, recognize, and treat drug-induced nephrotoxicity. Cleve Clin J Med. 2002 Apr;69(4):289-90, 293-4, 296-7 passim. Review.
Iglesias JI, Nasr SH, Markowitz GS, D'Agati VD. AIDS, nephrotic-range proteinuria, and renal failure. Kidney Int. 2006 Jun;69(11):2107-10.
Coca S, Perazella MA. Rapid communication: acute renal failure associated with tenofovir: evidence of drug-induced nephrotoxicity. Am J Med Sci. 2002 Dec;324(6):342-4.
Antoniou T, Raboud J, Chirhin S, Yoong D, Govan V, Gough K, Rachlis A, Loutfy M. Incidence of and risk factors for tenofovir-induced nephrotoxicity: a retrospective cohort study. HIV Med. 2005 Jul;6(4):284-90.
Schaaf B, Aries SP, Kramme E, Steinhoff J, Dalhoff K. Acute renal failure associated with tenofovir treatment in a patient with acquired immunodeficiency syndrome. Clin Infect Dis. 2003 Aug 1;37(3):e41-3. Epub 2003 Jul 22.
Karras A, Lafaurie M, Furco A, Bourgarit A, Droz D, Sereni D, Legendre C, Martinez F, Molina JM. Tenofovir-related nephrotoxicity in human immunodeficiency virus-infected patients: three cases of renal failure, Fanconi syndrome, and nephrogenic diabetes insipidus. Clin Infect Dis. 2003 Apr 15;36(8):1070-3. Epub 2003 Apr 4.
Créput C, Gonzalez-Canali G, Hill G, Piketty C, Kazatchkine M, Nochy D. Renal lesions in HIV-1-positive patient treated with tenofovir. AIDS. 2003 Apr 11;17(6):935-7.
Verhelst D, Monge M, Meynard JL, Fouqueray B, Mougenot B, Girard PM, Ronco P, Rossert J. Fanconi syndrome and renal failure induced by tenofovir: a first case report. Am J Kidney Dis. 2002 Dec;40(6):1331-3.
Levey AS, Coresh J, Balk E, Kausz AT, Levin A, Steffes MW, Hogg RJ, Perrone RD, Lau J, Eknoyan G; National Kidney Foundation. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med. 2003 Jul 15;139(2):137-47. Erratum in: Ann Intern Med. 2003 Oct 7;139(7):605.
Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41.
Sokoll LJ, Russell RM, Sadowski JA, Morrow FD. Establishment of creatinine clearance reference values for older women. Clin Chem. 1994 Dec;40(12):2276-81.
Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70.

ClinicalTrials.gov Identifier: NCT00551655     History of Changes
Other Study ID Numbers: COL109413
First Submitted: October 30, 2007
First Posted: October 31, 2007
Last Update Posted: November 6, 2007
Last Verified: October 2007

Keywords provided by AIDS Arms Inc.:
Human Immunodeficiency Viruses
Glomerular Filtration Rate
Tenofovir
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Renal Insufficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Kidney Diseases
Urologic Diseases


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