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Effect on HIV Medications on EPC Cells

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ClinicalTrials.gov Identifier: NCT03782142
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sabyasachi Sen, George Washington University

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.


Condition or disease Intervention/treatment
AIDS Drug: Tenofovir Drug: Rilpivirine Drug: Prezcobix Drug: Dolutegravir

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: What is the Impact of Current HIV Medication Regimens on Endothelial Dysfunction?
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
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
Drug: Tenofovir
TAF (tenofovir alafenamide) or TDF(tenofovir disoproxil fumarate)

Drug: Rilpivirine
NNRTI

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]
Drug: Tenofovir
TAF (tenofovir alafenamide) or TDF(tenofovir disoproxil fumarate)

Drug: Prezcobix
PI

Group C NRTI + II
NRTI such as TAF (tenofovir alafenamide) or TDF (tenofovir disoproxil fumarate) and an Integrase inhibitor (dolutegravir)
Drug: Tenofovir
TAF (tenofovir alafenamide) or TDF(tenofovir disoproxil fumarate)

Drug: Dolutegravir
II




Primary Outcome Measures :
  1. CD34+/ total MNC percentage [ Time Frame: Week 0, Single Time Point ]
    Percent of CD34+ cells over total Mononuclear cell

  2. Colony Formation Capacity - Numbers of Colony formed [ Time Frame: Week 0, Single Time Point ]
  3. Migratory function in response to SDF1α [ Time Frame: Week 0, Single Time Point ]
    How much the CD34+ cells migrate in response to SDF1a

  4. Targeted gene expression of EPCs [ Time Frame: Week 0, Single Time Point ]
    Gene expression


Secondary Outcome Measures :
  1. Concentration of Serum Insulin [ Time Frame: Week 0, Single Time Point ]
    to assess insulin resistance

  2. Lipid Profile [ Time Frame: Week 0, Single Time Point ]
    Cholesterol, LDL, HDL and TAG

  3. Concentration Serum Leptin [ Time Frame: Week 0, Single Time Point ]
    appetite controlling hormone

  4. Arterial Stiffness through measuring Pulse wave Velocity [ Time Frame: Week 0, Single Time Point ]
    through Pulse velocity



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Males from 40-70, with a Diagnosis of HIV, currently on HAART.
Criteria

Inclusion Criteria:

  1. 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,
  2. Body Mass Index (BMI) between 25.0-39.9 (both inclusive)
  3. eGFR ≥ 50 mL/min/1.73 m2 by MDRD.

Exclusion Criteria:

  1. Uncontrolled hyperglycemia with random blood glucose >200 mg/dL (>13.3 mmol/L)
  2. Liver disease with ALT, AST or ALP x3 ULN
  3. Subjects with HCV and HBV and detectable HCV RNA or HBV DNA
  4. GFR <50 mL/min/1.73 m2 by MDRD
  5. Prior surgery with chronic malabsorption (eg, bariatric) in prior 1 year
  6. Clinically significant RBC disorders such as hemoglobinopathies
  7. Chronic use of anti-inflammatory drugs for the last 3 months
  8. On statin medications (ASCVD score less than or equal to 7.5%)
  9. Use of consistent long-term steroid medication (oral, inhaled, injected) in last 1 month
  10. Treatment with a strong cytochrome P450 3A4 (CYP34A) or P-gp inducer (ie:Rifampin)
  11. Active smokers, Active wounds or recent surgery within 1 month
  12. Untreated hyper/hypothyroidism
  13. Implanted devices (eg. Pacemaker) that may interact with Tanita scale
  14. Any other clinical condition that would jeopardize patient safety while participating
  15. Women who are pregnant or breastfeeding
  16. Chronic or persistent alcohol or drug abuse
  17. Hypertriglyceridemia above 500mg/dl.
  18. Prisoners or subjects who are involuntarily incarcerated
  19. Subjects who are compulsorily detained for treatment of either a psychiatric illness
  20. Participation in another trial with an investigational drug within 30 days prior to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782142


Contacts
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Contact: Hassan Awal, MD 2027412389 hawal@mfa.gwu.edu
Contact: Sabyasachi Sen, MD, PhD (202)-994-8560

Locations
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United States, District of Columbia
The GW Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Hassan Awal, MD    202-741-2389    hawal@mfa.gwu.edu   
Principal Investigator: Sabyasachi Sen, MD         
Sponsors and Collaborators
Sabyasachi Sen

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Responsible Party: Sabyasachi Sen, Associate Professor, Dept. of Medicine (Division of Endocrinology), George Washington University
ClinicalTrials.gov Identifier: NCT03782142     History of Changes
Other Study ID Numbers: 180510
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Tenofovir
Dolutegravir
Rilpivirine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors