Clinical trial NCT00551655: Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients
Official title: Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Viruses
Kidney Failure
HIV Infections
Keywords: Human Immunodeficiency Viruses
Glomerular Filtration Rate
Tenofovir
Treatment Experienced
Lead sponsor: AIDS Arms Inc.
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-10-31
Enrollment: 684
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: 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.

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 criteria: Inclusion Criteria:

* HIV positive patients seen between 2003 and 2006

Exclusion Criteria:

* Fewer than two laboratory results

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Peabody Health Center
state: Texas
Study officials:
affiliation: AIDS Arms Inc.
name: Keith Rawlings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roling 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. doi: 10.1086/503566. Epub 2006 Apr 11.
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citation: 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. doi: 10.1086/368314. Epub 2003 Apr 4.
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