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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
AIDS Arms Inc.
ClinicalTrials.gov Identifier:
NCT00551655
First received: October 30, 2007
Last updated: November 5, 2007
Last verified: October 2007

October 30, 2007
November 5, 2007
May 2007
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Complete list of historical versions of study NCT00551655 on ClinicalTrials.gov Archive Site
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Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients
Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
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  • Human Immunodeficiency Viruses
  • Kidney Failure
  • HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
684
September 2007
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Inclusion Criteria:

  • HIV positive patients seen between 2003 and 2006

Exclusion Criteria:

  • Fewer than two laboratory results
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00551655
COL109413
No
Not Provided
AIDS Arms Inc.
GlaxoSmithKline
Principal Investigator: Keith Rawlings, MD AIDS Arms Inc.
AIDS Arms Inc.
October 2007

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