Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients
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|ClinicalTrials.gov Identifier: NCT00551655|
Recruitment Status : Completed
First Posted : October 31, 2007
Last Update Posted : November 6, 2007
|Condition or disease|
|Human Immunodeficiency Viruses Kidney Failure HIV Infections|
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.
|Study Type :||Observational|
|Actual Enrollment :||684 participants|
|Official Title:||Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients|
|Study Start Date :||May 2007|
|Actual Study Completion Date :||September 2007|
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
|United States, Texas|
|Peabody Health Center|
|Dallas, Texas, United States, 75215|
|Principal Investigator:||Keith Rawlings, MD||AIDS Arms Inc.|