Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: lopinavir/ritonavir plus maraviroc
Intervention description: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
Intervention MeSH terms: Ritonavir; Lopinavir; Maraviroc
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Protease Inhibitor; CCR5 Co-receptor Antagonist; treatment naive

Summary:

      The primary objective of this pilot study is to assess the efficacy of lopinavir/ritonavir
      (Kaletra, a protease inhibitor, PI) when used in combination with maraviroc (Selzentry, an
      HIV entry inhibitor) for the treatment of antiretroviral naïve HIV infected patients. Twenty
      patients will be enrolled and studied for 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has signed and dated approved informed consent form.

          -  There is confirmed laboratory diagnosis of HIV infection (positive ELISA HIV antibody
             test confirmed by Western blot, p24 antigen assay, quantitative HIV-1 RNA assay, or
             HIV culture).

          -  The patient is at least 18 years of age.

          -  ART-naïve, lopinavir/ritonavir susceptible on genotypic testing, CCR5-tropic virus on
             Trofile testing (ESTA).

          -  Negative pregnancy test within 72 hours prior to start of study for women of
             childbearing potential.

          -  Females of childbearing potential and males must utilize effective barrier
             contraception.

          -  HIV RNA greater than 1,000 copies per mL at entry.

          -  Liver enzymes (AST, ALT) < 3 times the upper limit of normal.

        Exclusion Criteria:

          -  Patients who are pregnant or breast-feeding.

          -  Active alcohol or substance abuse sufficient, in the Investigator's opinion that makes
             compliance to the study protocol unlikely.

          -  Suspected or active HIV-related opportunistic infection or condition requiring acute
             therapy within 30 days of entry into the trial.

          -  Patients on therapy for hepatitis B.

          -  Patients with hepatitis B surface antigen, or any evidence of active hepatitis B such
             as positive hepatitis B DNA and/or presence of hepatitis e antigen or e antibody.

          -  Acute hepatitis B or C within 60 days of entry.

          -  Patients harboring preexistent co-receptor CXCR4 tropic or dual-or mixed-tropic HIV.

          -  Patients harboring HIV resistant to lopinavir/ritonavir on genotypic testing.

          -  The presence of decompensated heart failure, myocardial infarction within 1 year,
             bypass surgery, severe vascular disease, or active hepatobiliary disease.

          -  Concomitant use of rifampin, ergot derivatives (i.e. dihydroergotamine, ergotamine),
             cisapride, lovastatin, simvastatin, triazolam, orally administered midazolam,
             carbamazepine, phenytoin, St. John's wort, ketoconazole, itraconazole, clarithromycin,
             telithromycin, amiodarone, bepridil, flecainide, propafenone, quinidine, voriconazole
             or nefazodone.

          -  Patients with concomitant diagnosis of malignancy or cancer other than basal cell
             carcinoma within the past 5 years.

          -  Concomitant use of investigational agents including the use of any investigational
             vaccines.

          -  Any other clinical conditions or prior therapy that, in the opinion of the
             investigator, would make the patient unsuitable for study, or unable to comply with
             the dosing requirements.