Status:
COMPLETED
HIV and Kidney Function Study
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
University of Alabama at Birmingham
Conditions:
HIV Infections
AIDS
Eligibility:
All Genders
18+ years
Brief Summary
Current methods to assess kidney function have not been tested in people who have HIV/AIDS population. Given effects of the disease as well as potential effects of the medications, it is possible that...
Detailed Description
General description: The overall study procedure requires assessment of eligibility and safety for inclusion in the study (through a "screening questionnaire" and "health screening visit") and if elig...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older
- Confirmed HIV positive status
- Treatment with stable antiretroviral medications for a period of at least 3 months prior to the study
Exclusion
- Persons less than 18 years of age. Children are excluded due to the fact that they are still growing. Growth causes levels of creatinine to change differently than in adults, thus requiring the use of age-specific GFR estimating equations.
- Women who are either pregnant or who intend to become pregnant during the period of time in which the study visits will occur.
- Allergy to any of the contrast media used or a known allergy to iodine or shellfish. Subjects who are not sure if they have an iodine allergy because they have not eaten shellfish nor have never received contrast dye will be excluded from participation.
- Inability to cease taking medications that affect creatinine levels (e.g. trimethoprim containing medications, cimetidine) for one week prior to the study visit
- Inability to maintain stable regimen of non-steroidal anti-inflammatory agents, angiotension converting enzyme inhibitors and or angiotension receptor blockers for one week prior to study visit.
- Women who are breastfeeding
- Current treatment with amiodarone
- Current treatment with metformin
- Acute exacerbation of asthma or chronic obstructive lung disease in the past three months requiring hospitalization or oral steroid therapy
- Inadequate venous access
- People with kidney failure (currently undergoing or having received peritoneal dialysis or hemodialysis treatment within the past three months or estimated GFR (eGFR) \< 15 ml/min per 1.73 m2)
- End stage conditions such as cirrhosis
- Active treatment for cancer
- Progressive neurological diseases
- Severe gastric immotility
- History of cognitive or physical impairments that will not allow completion of the study
- Inability to provide informed consent
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT00905151
Start Date
January 1 2009
End Date
June 1 2010
Last Update
March 15 2017
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111