HIV Infections Clinical Trial
Official title:
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 Model: Cohort, Time Perspective: Retrospective
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