Impact of Drug Therapy and Co-Morbidities on the Development of Renal Impairment in HIV-Infected Patients
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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.
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 |
Enrollment: | 684 |
Study Start Date: | May 2007 |
Study Completion Date: | September 2007 |
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV positive patients seen between 2003 and 2006
Exclusion Criteria:
- Fewer than two laboratory results
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Publications:
ClinicalTrials.gov Identifier: | NCT00551655 History of Changes |
Other Study ID Numbers: | COL109413 |
Study First Received: | October 30, 2007 |
Last Updated: | November 5, 2007 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by AIDS Arms Inc.:
Human Immunodeficiency Viruses Glomerular Filtration Rate Tenofovir Treatment Experienced |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Renal Insufficiency Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on March 10, 2013