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Immune Activation and Drug Absorption in HIV-Infected Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Drexel University
Sponsor:
Information provided by (Responsible Party):
Christopher Vinnard, Drexel University College of Medicine
ClinicalTrials.gov Identifier:
NCT01845298
First received: April 29, 2013
Last updated: May 1, 2014
Last verified: May 2014

April 29, 2013
May 1, 2014
June 2014
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01845298 on ClinicalTrials.gov Archive Site
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Immune Activation and Drug Absorption in HIV-Infected Patients
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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.

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Interventional
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Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV Infection
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.
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.
Intervention: Drug: Rifampicin 600 mg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
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December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected males and females, between the ages of 21 and 45 years.
  • Naïve to antiretroviral therapy
  • T cell count greater than 350 cells/mm3
  • Body Mass Index (BMI) greater or equal to 19 and less than or equal to 33.
  • Weight greater than 60 kilograms.
  • Ability and willingness to provide informed consent.
  • Ability to swallow oral medications

Exclusion Criteria:

  • Breastfeeding.
  • Allergy or sensitivity to rifampicin.
  • Prior history of documented active tuberculosis infection.
  • Receipt of any investigational therapy, chemotherapy, or immune modulatory agents within 42 days prior to study entry.
  • The following laboratory values obtained within 42 days prior to study entry:

Hemoglobin < 12.0 g/dL; Females: Hemoglobin < 11.0 g/dL Platelet count < 100,000/mm3 AST, ALT, and bilirubin > 5x ULN An estimated creatinine clearance < 80 mL/min based on the Cockroft-Gault equation

  • Positive blood test for latent tuberculosis infection (T-SPOT)
  • Female participants of reproductive potential must have a negative serum or urine pregnancy test performed with 28 days prior to study entry.

"Female participants of reproductive potential" is defined as women who have reached menarche or who have not been post-menopausal for at least 24 consecutive months (i.e. who have had menses within the preceding 24 months) or who have not undergone surgical sterilization (e.g. hysterectomy, or bilateral oophorectomy or salpingectomy).

  • Female participants of reproductive potential that are using oral contraceptive pills (OCPs) must be willing to use barrier precautions for contraception for at least 7 days following each study visit.
  • Use of any of the following prescription medications within 30 days prior to study entry, which may have drug-drug interactions with rifampicin, including (but not limited to):

    • Anti-coagulants (warfarin)
    • Cardiac drugs (digoxin, quinidine, verapamil, nifedipine, metoprolol, atenolol, carvedilol)
    • Hypoglycemics (rosiglitazone, pioglitazone, glipizide, repaglinide)
    • Proton pump inhibitors (omeprazole, esomeprazole,
    • Immune modulators (tacrolimus, cyclosporine)
    • Corticosteroids (dexamethasone, prednisone, hydrocortisone)
    • H2 blockers (ranitidine, cimetidine)
    • HMG CoA reductase inhibitors (atorvastatin, pravastatin, simvastatin)
    • Benzodiazepines (alprazolam, diazepam, midazolam, triazolam)
    • CNS-acting drugs (amitriptyline, buproprion, clozapine, phenytoin)
  • Evidence of current ongoing tobacco use, illicit drug use, or average alcohol use of greater than 2 drinks per day.
  • Any illness that, in the opinion of the study investigator, might confound the results of the study, or pose an additional risk to the subject by his or her participation in the study.
Both
21 Years to 45 Years
No
Contact: Christopher Vinnard, MD 215 762 6555 christopher.vinnard@drexelmed.edu
United States
 
NCT01845298
TMC114HIV4076
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Christopher Vinnard, Drexel University College of Medicine
Christopher Vinnard
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Drexel University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP