N/A
N=206
HIV and Kidney Function Study
HIV Infections · AIDS
Bottom Line
View on ClinicalTrials.gov: NCT00905151 ↗Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Performance of Glomerular Filtration Rate (GFR) Estimating Equations — 10.9; 5.4; 4.3; 6.4 mL/min per 1.73 m^2
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts Medical Center
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance of Glomerular Filtration Rate (GFR) Estimating Equations |
10.9; 5.4; 4.3; 6.4 | — |
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 the methods currently used to assess kidney function are not accurate. This purpose of this study is to evaluate methods to assess kidney function the HIV population. The investigators hypothesize that tenofovir causes a decrease in the secretion of creatinine which would cause an elevation in blood levels without affecting actual glomerular filtration rate (GFR).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00905151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.