Status:
COMPLETED
Effect on HIV Medications on EPC Cells
Lead Sponsor:
Sabyasachi Sen
Conditions:
AIDS
Eligibility:
MALE
40-70 years
Brief Summary
This is a 3 arm, non-Interventional pilot single time point cross sectional study for the duration of 1 year. Total of 30 candidates (10 in each Group) will be enrolled into three different groups tak...
Detailed Description
Metabolic and endocrine perturbations including insulin resistance, diabetes, and dyslipidemia have been of significant concern in human immunodeficiency virus (HIV)-infected individuals. HIV-infected...
Eligibility Criteria
Inclusion
- Male only (as gender variation of progenitor cells along with effect of estrogen, may lead to difficulty in data interpretation), Age above 40, but less than 70 years,
- Body Mass Index (BMI) between 25.0-39.9 (both inclusive)
- eGFR ≥ 50 mL/min/1.73 m2 by MDRD.
Exclusion
- Uncontrolled hyperglycemia with random blood glucose \>200 mg/dL (\>13.3 mmol/L)
- Liver disease with ALT, AST or ALP x3 ULN
- Subjects with HCV and HBV and detectable HCV RNA or HBV DNA
- GFR \<50 mL/min/1.73 m2 by MDRD
- Prior surgery with chronic malabsorption (eg, bariatric) in prior 1 year
- Clinically significant RBC disorders such as hemoglobinopathies
- Chronic use of anti-inflammatory drugs for the last 3 months
- On statin medications (ASCVD score less than or equal to 7.5%)
- Use of consistent long-term steroid medication (oral, inhaled, injected) in last 1 month
- Treatment with a strong cytochrome P450 3A4 (CYP34A) or P-gp inducer (ie:Rifampin)
- Active smokers, Active wounds or recent surgery within 1 month
- Untreated hyper/hypothyroidism
- Implanted devices (eg. Pacemaker) that may interact with Tanita scale
- Any other clinical condition that would jeopardize patient safety while participating
- Women who are pregnant or breastfeeding
- Chronic or persistent alcohol or drug abuse
- Hypertriglyceridemia above 500mg/dl.
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric illness
- Participation in another trial with an investigational drug within 30 days prior to consent
Key Trial Info
Start Date :
November 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03782142
Start Date
November 1 2018
End Date
December 14 2021
Last Update
March 22 2022
Active Locations (1)
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1
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037