Immune Activation and Drug Absorption in HIV-Infected Patients
The investigators' objective is to describe the variability of rifampicin absorption, markers of inflammation and gut damage, intestinal absorptive capacity, and intestinal permeability among HIV-infected volunteers. Rifampicin is the least well absorbed of the first-line anti-tuberculosis drugs. Rifampicin malabsorption is frequently observed in HIV-infected patients with active tuberculosis, but cannot be predicted by patient factors such as CD4+ T cell count, viral load, or the presence of diarrhea. The mechanisms for rifampicin malabsorption in HIV-infected patients are unknown. An understanding of mechanisms for rifampicin malabsorption could eventually lead to new therapeutic targets, with the ultimate goal of improving HIV/tuberculosis treatment outcomes.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
- Rifampicin Absorption (Ka) [ Time Frame: Baseline ] [ Designated as safety issue: No ]The investigators will perform a pharmacokinetic study to assess rifampicin absorption among study subjects. Pharmacokinetic modeling will be used to assess the absorption rate constant (Ka) for each subject.
|Study Start Date:||June 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: HIV-infected subjects
HIV-infected subjects who have not yet initiated highly active antiretroviral therapy (HAART). All enrolled subjects will receive a single dose of rifampicin 600 mg.
Drug: Rifampicin 600 mg
The investigators will administer a single dose of rifampicin 600 mg to study subjects in order to conduct a pharmacokinetic study of rifampicin absorption.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01845298
|Contact: Christopher Vinnard, MD||215 762 firstname.lastname@example.org|
|United States, Pennsylvania|
|Drexel University College of Medicine||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19102|
|Contact: Christopher Vinnard, MD 215-762-6555 email@example.com|
|Principal Investigator: Christopher Vinnard, MD|