Effect on HIV Medications on EPC Cells
What is the Impact of Current HIV Medication Regimens on Endothelial Dysfunction?
1 other identifier
observational
22
1 country
1
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 taking three different Antiretroviral regimen. Based on current regimens that are commonly used (2017-2018 ART guidelines), our groups will include NRTI such as TAF (tenofovir alafenamide) or TDF(tenofovir disoproxil fumarate) plus one of the following: Group A: an NNRTI (Non-nucleoside reverse transcriptase inhibitor, Rilpivirine Group B a boosted Protease Inhibitor: Prezcobix- \[darunavir+cobicistat combination\] Group C: an Integrase inhibitor (dolutegravir) Once Informed Consent Process is obtained, blood will be drawn (55 ml) for stem/progenitor cell harvest and 15-20mls for biochemistry analysis. The Investigators will also obtain weight, waist-circumference, BP, pulse, BMI, Tanita body composition scale measures (which gives us body habitus measurements) and arterial stiffness measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2021
CompletedMarch 22, 2022
March 1, 2022
2 years
October 17, 2018
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
CD34+/ total MNC percentage
Percent of CD34+ cells over total Mononuclear cell
Week 0, Single Time Point
Colony Formation Capacity - Numbers of Colony formed
Week 0, Single Time Point
Migratory function in response to SDF1α
How much the CD34+ cells migrate in response to SDF1a
Week 0, Single Time Point
Targeted gene expression of EPCs
Gene expression
Week 0, Single Time Point
Secondary Outcomes (4)
Concentration of Serum Insulin
Week 0, Single Time Point
Lipid Profile
Week 0, Single Time Point
Concentration Serum Leptin
Week 0, Single Time Point
Arterial Stiffness through measuring Pulse wave Velocity
Week 0, Single Time Point
Study Arms (3)
Group A NRTI + NNRTI
Based on current regimens that are commonly used (2017-2018 ART guidelines), our groups will include NRTI such as TAF (tenofovir alafenamide) or TDF (tenofovir disoproxil fumarate) and an NNRTI (Non-nucleoside reverse transcriptase inhibitor, Rilpivirine
Group B NRTI + boosted PI
NRTI such as TAF (tenofovir alafenamide) or TDF (tenofovir disoproxil fumarate) and a boosted Protease Inhibitor: Prezcobix- \[darunavir+cobicistat combination\]
Group C NRTI + II
NRTI such as TAF (tenofovir alafenamide) or TDF (tenofovir disoproxil fumarate) and an Integrase inhibitor (dolutegravir)
Interventions
TAF (tenofovir alafenamide) or TDF(tenofovir disoproxil fumarate)
Eligibility Criteria
Males from 40-70, with a Diagnosis of HIV, currently on HAART.
You may qualify if:
- 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.
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sabyasachi Senlead
Study Sites (1)
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Related Publications (1)
Elzarki AF, Nandula SR, Awal H, Simon GL, Sen S. Cardiovascular disease (CVD) risk assessment of HIV medication regimens using hematopoietic CD34+ progenitor cells. Stem Cell Res Ther. 2022 Mar 7;13(1):103. doi: 10.1186/s13287-022-02775-6.
PMID: 35255964DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Dept. of Medicine (Division of Endocrinology)
Study Record Dates
First Submitted
October 17, 2018
First Posted
December 20, 2018
Study Start
November 1, 2018
Primary Completion
November 12, 2020
Study Completion
December 14, 2021
Last Updated
March 22, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share