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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00551655
Recruitment Status : Completed
First Posted : October 31, 2007
Last Update Posted : November 6, 2007
Information provided by:
AIDS Arms Inc.

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.

Condition or disease Phase
Human Immunodeficiency Viruses Kidney Failure HIV Infections Phase 4

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.

Study Type : Observational
Actual Enrollment : 684 participants
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
Study Start Date : May 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00551655

United States, Texas
Peabody Health Center
Dallas, Texas, United States, 75215
Sponsors and Collaborators
AIDS Arms Inc.
Principal Investigator: Keith Rawlings, MD AIDS Arms Inc.

Publications: Identifier: NCT00551655     History of Changes
Other Study ID Numbers: COL109413
First Posted: October 31, 2007    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: October 2007

Keywords provided by AIDS Arms Inc.:
Human Immunodeficiency Viruses
Glomerular Filtration Rate
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Renal Insufficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Kidney Diseases
Urologic Diseases