Effects of Treatment With Aprepitant (Emend®) in HIV Infected Individuals. 375 mg Dose

This is an interventional treatment trial for HIV Infection focused on measuring HIV infection, Neurokinin-1 receptor antagonist, CCR5 expression, Treatment Naive Read More

Inclusion Criteria:

• HIV-1 infection, as documented by a rapid HIV test or any FDA-Approved HIV-1 Enzyme or Chemiluminescence Immunoassay (E/CIA) test kit and confirmed by Western blot at any time prior to study entry.
• CD4+ cell count >= 350/mm3 obtained within 90 days prior to study entry
• Plasma HIV-1 RNA of >=2,000 copies/mL as measured by any standard assay and performed within 90 days prior to study entry.
• CCR5 tropic virus exclusively as determined by the Monogram tropism assay (PhenoSense Entry™) to be performed within 90 days of study entry.

• Laboratory values obtained within 30 days prior to study entry, as follows:

  • Absolute neutrophil count (ANC) >= 750/mm3
  • Hemoglobin >= 10.0 g/dL
  • Platelet count >= 100,000/mm3
  • Creatinine <= 2 x ULN
  • AST (SGOT), ALT (SGPT), and alkaline phosphatase <= 2 x ULN
  • Total bilirubin <= 2.5 x ULN
  • Albumin >= 3 g/dL
• Female subjects of reproductive potential must have a negative spot urine pregnancy test result (with a sensitivity of at least 50 mIU/mL) performed at entry, prior to starting initial study treatment.
• All subjects must agree not to participate in a conception process while on study drug and for 30 days after stopping the medication.
• Karnofsky performance score >= 80 within 30 days prior to study entry.
• Men and women > 18 years of age.
• Ability and willingness of subject to give written informed consent.
• Willing to return for a follow-up visit on day 42.
• Subjects taking any precautionary concomitant medications must be on stable doses for >8 weeks prior to study entry and have no plans to change medications or doses for the duration of the study.

Exclusion Criteria:

• Receipt of antiretroviral treatment within the 16 weeks prior to study entry or intent to initiate antiretroviral therapy within 60 days after entry.
• Diabetes requiring treatment with oral hypoglycemics or insulin therapy.
• Pregnancy within 90 days prior to study entry.
• Breast-feeding.
• Use of drugs that are inhibitors or inducers of metabolism by the cytochrome P450 CYP3A4 or CYP2C9 (such as warfarin and phenytoin) within 7 days of study entry.
• Use of systemic corticosteroids or hormonal agents within 90 days prior to study entry.
• Use of any immunomodulator, HIV vaccines, or investigational therapy within 90 days prior to study entry.
• Any vaccination within 30 days prior to study entry.
• Use of systemic cytotoxic chemotherapy within 90 days prior to study entry.
• History of allergy to aprepitant or its formulations.
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• History of chronic active hepatitis B or C infection or severe hepatic dysfunction (Child-Pugh score > 9) regardless of etiology
• Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
• Weight < 40 kg or 88 lbs. within 90 days prior to study entry.
• History of severe psychiatric comorbidities, such as depression, schizophrenia, mania, psychosis.