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Immune Activation and Drug Absorption in HIV-Infected Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Drexel University.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Christopher Vinnard, Drexel University College of Medicine Identifier:
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 ]
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 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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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 Identifier (NCT Number) in Medline.
Unknown status
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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.
Sexes Eligible for Study: All
21 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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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