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The Lymphoid Tissue Pharmacology of Antiretroviral Drugs

NCT02707926 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-08-24

No results posted yet for this study

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).

Conditions

  • HIV Infection

Interventions

DRUG

Anti-HIV Agents

Therapy to treat HIV infection

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Tim Schacker, MD · University of Minnesota

  • Courtney V Fletcher, PharmD · University of Nebraska

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-25
Primary Completion
2023-08-17
Completion
2023-08-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02707926 on ClinicalTrials.gov