Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)

As patients with HIV are living longer it is important to explore antiretroviral treatments
which may reduce the development of long term complications while preserving future HIV
treatment options. This trial explores an antiretroviral treatment regimen which does not
include the nucleoside reverse transcriptase inhibitor class which is thought to have
long-term toxicity. This is a non-randomized, open label trial in participants meeting entry
requirements.

Participants will be evaluated at screening, baseline,and weeks 4, 8, 12, 24, 36, and 48 to
include clinical assessments as well as laboratory assessments.

An interim analysis will be performed when all patients have reached the week 24 visit.

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.