Immune Activation and Drug Absorption in HIV-Infected Patients

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.