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The Lymphoid Tissue Pharmacology of Antiretroviral Drugs

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ClinicalTrials.gov Identifier: NCT02707926
Recruitment Status : Not yet recruiting
First Posted : March 14, 2016
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Courtney Fletcher, University of Nebraska

Brief Summary:

Hypothesis:

Antiretroviral drugs (ARVs) with enhanced LT penetration characteristics in vitro and in macaques will translate into an ARV regimen with increased LN and GALT concentrations and a faster decay and more potent suppression of HIV replication in LT in HIV-infected persons.

Objectives:

  1. Determine lymph nodes (LN) and gut-associated lymphoid tissue (GALT) pharmacokinetics (PK) in HIV-infected persons on an antiretroviral drug (ARV) regimen.
  2. Determine virological responses of antiretroviral therapy in plasma, peripheral blood mononuclear cells (PBMCs) and lymphoid tissue (LT).

Condition or disease Intervention/treatment
HIV Infection Drug: Anti-HIV Agents

Detailed Description:

This is a single-center study of 18 ARV naïve, HIV infected persons to assess impact of an ARV regimen on lymph node (LN) and (GALT) virus reservoirs.

All participants will give informed consent. At baseline, plasma and PBMCs will be obtained and all subjects will have an incisional biopsy of an inguinal LN and pinch biopsy of ileum and rectum via colonoscopy. The selected LT-enhanced ARV regimen will be initiated. Participants will return to the clinic at weeks 2 and 4 and then monthly for safety evaluations, CD4 T cell counts, plasma HIV-RNA and ARV drug concentrations in plasma and PBMCs. An intensive PK study will be performed at week 2. At months 3 and 6, the inguinal LN biopsy and pinch biopsies of ileum and rectum will be repeated.


Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Lymphoid Tissue Pharmacology of Antiretroviral Drugs
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Drug: Anti-HIV Agents
    Therapy to treat HIV infection


Primary Outcome Measures :
  1. Ratio of antiretroviral drug concentration in lymph node (LN) to peripheral blood mononuclear cells (PBMCs) [ Time Frame: 6 months ]
  2. Lymph node (LN) residual viremia. [ Time Frame: 6 months ]
    Quantification of residual viremia in lymph node (LN) at 6 months of therapy as measured by digital droplet polymerase chain reaction (PCR), which can quantify as low as 50 copies/million cells.


Biospecimen Retention:   Samples Without DNA
Blood, urine, lymph node biopsy, colonoscopy biopsy of ileum and rectum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eighteen (18) antiretroviral drug (ARV)-naive, HIV-infected persons who are going to initiate ARV therapy will be recruited at the University of Minnesota. Study entry is open to adults regardless of race or ethnic background. While there will be every effort to seek out and include minority participants from both genders, the patient population is expected to be no different than that of the HIV infected population in Minnesota.
Criteria

Inclusion Criteria:

  1. Antiretroviral drug (ARV)-naive, HIV-infected individuals
  2. Aged 18 years or over
  3. Agree to initiating ARV therapy
  4. BMI ≤ 30
  5. Inguinal lymph node(s) identifiable by ultrasound at enrollment
  6. Screening plasma HIV RNA > 40,000 copies/mL
  7. Screening CD4 count > 200 cells/mm3
  8. Women of child bearing potential must agree to use effective contraception while on the study.
  9. Screening viral isolates demonstrate genotype sensitivity to chosen antiretroviral therapy (ART) regimen.
  10. Able to provide voluntary written consent

Exclusion Criteria:

  1. Previous ARV therapy
  2. Contraindications to ARV regimen (e.g., comorbid conditions or drug interactions), or study procedures as determined by the principal investigator.
  3. Planning or current pregnancy or breastfeeding
  4. History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorder, which, in the opinion of the enrolling physician, may put the participant at risk because of participation in the study, influence the results of the study, or affect the participant's ability to participate in the study.
  5. Inability to comply with study procedures per enrolling physician discretion

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): NCT02707926


Contacts
Contact: Ann Thorkelson, MN, RN 612-625-7472 segu0017@umn.edu
Contact: Tim Schacker, MD 612-624-9955 schac008@umn.edu

Sponsors and Collaborators
University of Nebraska
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Tim Schacker, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Courtney V Fletcher, PharmD University of Nebraska

Publications:
Responsible Party: Courtney Fletcher, Dean and Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02707926     History of Changes
Other Study ID Numbers: 1601M83126
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The results of this trial will be of interest to the HIV research and medical communities. We expect to submit the data from the main analysis within 6 months of completing the work. We will publish the results in a major scientific journal and present the results at a major scientific meeting (e.g., CROI). Subsequent analyses will be presented at national and international HIV meetings. Data generated under this project, and any intellectual property, will be administered in accordance with NIH policies, including the NIH Data Sharing Policy the NIH Public Access Policy.

Additional relevant MeSH terms:
HIV Infections
Anti-HIV Agents
Anti-Retroviral Agents
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antiviral Agents
Anti-Infective Agents