The Lymphoid Tissue Pharmacology of Antiretroviral Drugs

0212-16-ET

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).

2023-03-25

2023-08-17

2023-08-17

Withdrawn

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

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2023-08-24