Home
Clinical Trials
NCT00551655

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

Last Updated: 2007-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

684 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Viruses Kidney Failure HIV Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Human Immunodeficiency Viruses Glomerular Filtration Rate Tenofovir Treatment Experienced

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HIV positive patients seen between 2003 and 2006

Exclusion Criteria

* Fewer than two laboratory results

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Keith Rawlings, MD

Role: PRINCIPAL_INVESTIGATOR

AIDS Arms Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peabody Health Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 16619164 (View on PubMed)

Izzedine H, Launay-Vacher V, Deray G. Antiviral drug-induced nephrotoxicity. Am J Kidney Dis. 2005 May;45(5):804-17. doi: 10.1053/j.ajkd.2005.02.010.

Reference Type BACKGROUND

PMID: 15861345 (View on PubMed)

Ross MJ, Klotman PE. HIV-associated nephropathy. AIDS. 2004 May 21;18(8):1089-99. doi: 10.1097/00002030-200405210-00002. No abstract available.

Reference Type BACKGROUND

PMID: 15166524 (View on PubMed)

Guo X, Nzerue C. How to prevent, recognize, and treat drug-induced nephrotoxicity. Cleve Clin J Med. 2002 Apr;69(4):289-90, 293-4, 296-7 passim. doi: 10.3949/ccjm.69.4.289.

Reference Type BACKGROUND

PMID: 11996200 (View on PubMed)

Iglesias JI, Nasr SH, Markowitz GS, D'Agati VD. AIDS, nephrotic-range proteinuria, and renal failure. Kidney Int. 2006 Jun;69(11):2107-10. doi: 10.1038/sj.ki.5000408. No abstract available.

Reference Type BACKGROUND

PMID: 16641932 (View on PubMed)

Coca S, Perazella MA. Rapid communication: acute renal failure associated with tenofovir: evidence of drug-induced nephrotoxicity. Am J Med Sci. 2002 Dec;324(6):342-4. doi: 10.1097/00000441-200212000-00011.

Reference Type BACKGROUND

PMID: 12495304 (View on PubMed)

Antoniou T, Raboud J, Chirhin S, Yoong D, Govan V, Gough K, Rachlis A, Loutfy M. Incidence of and risk factors for tenofovir-induced nephrotoxicity: a retrospective cohort study. HIV Med. 2005 Jul;6(4):284-90. doi: 10.1111/j.1468-1293.2005.00308.x.

Reference Type BACKGROUND

PMID: 16011534 (View on PubMed)

Schaaf B, Aries SP, Kramme E, Steinhoff J, Dalhoff K. Acute renal failure associated with tenofovir treatment in a patient with acquired immunodeficiency syndrome. Clin Infect Dis. 2003 Aug 1;37(3):e41-3. doi: 10.1086/376643. Epub 2003 Jul 22.

Reference Type BACKGROUND

PMID: 12884188 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12684922 (View on PubMed)

Creput C, Gonzalez-Canali G, Hill G, Piketty C, Kazatchkine M, Nochy D. Renal lesions in HIV-1-positive patient treated with tenofovir. AIDS. 2003 Apr 11;17(6):935-7. doi: 10.1097/00002030-200304110-00026. No abstract available.

Reference Type BACKGROUND

PMID: 12660548 (View on PubMed)

Verhelst D, Monge M, Meynard JL, Fouqueray B, Mougenot B, Girard PM, Ronco P, Rossert J. Fanconi syndrome and renal failure induced by tenofovir: a first case report. Am J Kidney Dis. 2002 Dec;40(6):1331-3. doi: 10.1053/ajkd.2002.36924.

Reference Type BACKGROUND

PMID: 12460055 (View on PubMed)

Levey AS, Coresh J, Balk E, Kausz AT, Levin A, Steffes MW, Hogg RJ, Perrone RD, Lau J, Eknoyan G; National Kidney Foundation. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med. 2003 Jul 15;139(2):137-47. doi: 10.7326/0003-4819-139-2-200307150-00013.

Reference Type BACKGROUND

PMID: 12859163 (View on PubMed)

Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.

Reference Type BACKGROUND

PMID: 1244564 (View on PubMed)

Sokoll LJ, Russell RM, Sadowski JA, Morrow FD. Establishment of creatinine clearance reference values for older women. Clin Chem. 1994 Dec;40(12):2276-81.

Reference Type BACKGROUND

PMID: 7988015 (View on PubMed)

Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999 Mar 16;130(6):461-70. doi: 10.7326/0003-4819-130-6-199903160-00002.

Reference Type BACKGROUND

PMID: 10075613 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COL109413

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

GlaxoSmithKline

AIDS Arms Inc.

Principal Investigators

Keith Rawlings, MD

Locations

Peabody Health Center

Countries

References

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.

Izzedine H, Launay-Vacher V, Deray G. Antiviral drug-induced nephrotoxicity. Am J Kidney Dis. 2005 May;45(5):804-17. doi: 10.1053/j.ajkd.2005.02.010.

Ross MJ, Klotman PE. HIV-associated nephropathy. AIDS. 2004 May 21;18(8):1089-99. doi: 10.1097/00002030-200405210-00002. No abstract available.

Guo X, Nzerue C. How to prevent, recognize, and treat drug-induced nephrotoxicity. Cleve Clin J Med. 2002 Apr;69(4):289-90, 293-4, 296-7 passim. doi: 10.3949/ccjm.69.4.289.

Iglesias JI, Nasr SH, Markowitz GS, D'Agati VD. AIDS, nephrotic-range proteinuria, and renal failure. Kidney Int. 2006 Jun;69(11):2107-10. doi: 10.1038/sj.ki.5000408. No abstract available.

Coca S, Perazella MA. Rapid communication: acute renal failure associated with tenofovir: evidence of drug-induced nephrotoxicity. Am J Med Sci. 2002 Dec;324(6):342-4. doi: 10.1097/00000441-200212000-00011.

Antoniou T, Raboud J, Chirhin S, Yoong D, Govan V, Gough K, Rachlis A, Loutfy M. Incidence of and risk factors for tenofovir-induced nephrotoxicity: a retrospective cohort study. HIV Med. 2005 Jul;6(4):284-90. doi: 10.1111/j.1468-1293.2005.00308.x.

Schaaf B, Aries SP, Kramme E, Steinhoff J, Dalhoff K. Acute renal failure associated with tenofovir treatment in a patient with acquired immunodeficiency syndrome. Clin Infect Dis. 2003 Aug 1;37(3):e41-3. doi: 10.1086/376643. Epub 2003 Jul 22.

Creput C, Gonzalez-Canali G, Hill G, Piketty C, Kazatchkine M, Nochy D. Renal lesions in HIV-1-positive patient treated with tenofovir. AIDS. 2003 Apr 11;17(6):935-7. doi: 10.1097/00002030-200304110-00026. No abstract available.

Verhelst D, Monge M, Meynard JL, Fouqueray B, Mougenot B, Girard PM, Ronco P, Rossert J. Fanconi syndrome and renal failure induced by tenofovir: a first case report. Am J Kidney Dis. 2002 Dec;40(6):1331-3. doi: 10.1053/ajkd.2002.36924.

Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.

Sokoll LJ, Russell RM, Sadowski JA, Morrow FD. Establishment of creatinine clearance reference values for older women. Clin Chem. 1994 Dec;40(12):2276-81.

Other Identifiers

COL109413