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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
AIDS Arms Inc.
ClinicalTrials.gov Identifier:
NCT00551655
First received: October 30, 2007
Last updated: November 5, 2007
Last verified: October 2007
  Purpose

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 Phase
Human Immunodeficiency Viruses
Kidney Failure
HIV Infections
Phase 4

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

Resource links provided by NLM:


Further study details as provided by AIDS Arms Inc.:

Enrollment: 684
Study Start Date: May 2007
Study Completion Date: September 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

Inclusion Criteria:

  • HIV positive patients seen between 2003 and 2006

Exclusion Criteria:

  • Fewer than two laboratory results
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551655

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

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 July 22, 2014