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
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.
- Determine lymph nodes (LN) and gut-associated lymphoid tissue (GALT) pharmacokinetics (PK) in HIV-infected persons on an antiretroviral drug (ARV) regimen.
- 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|
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|
|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|
- Drug: Anti-HIV Agents
Therapy to treat HIV infection
- Ratio of antiretroviral drug concentration in lymph node (LN) to peripheral blood mononuclear cells (PBMCs) [ Time Frame: 6 months ]
- 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
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
|Contact: Ann Thorkelson, MN, RNfirstname.lastname@example.org|
|Contact: Tim Schacker, MDemail@example.com|
|Principal Investigator:||Tim Schacker, MD||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Courtney V Fletcher, PharmD||University of Nebraska|