A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects

Inclusion Criteria:

- HIV-1 RNA ≥ 5000 copies/mL by Roche Amplicor 1.5v Primer

- More than 18 years of age

- Provide written informed consent and willingness to participate in and comply

- Less than 7 days of prior ART with any licensed or investigational compound

- Does not currently have or has not been treated for an active opportunistic infection
(OI) within 30 days of screening

- Vital signs, physical examination and laboratory results do not exhibit evidence of
acute illness

- A female who is a non-childbearing potentiator or if in child-bearing potential, has
a negative serum pregnancy test at screen and agrees to one of the following:
complete abstinence from intercourse from 2 weeks prior to administration of the
study drug, throughout the study, and for at least 2 weeks after completion or
premature discontinuation from the study to account for elimination of the
investigational drug. Should a patient decide to become sexually active during the
course of the study, she must be counseled and be willing to use one of the birth
control methods like double barrier method, intrauterine device, sterilization and
any other methods.

NOTE: Data are insufficient to exclude a clinically important interaction of LPV/r with
drugs, such as hormonal contraceptives, that are highly metabolized by the cytochrome P450
enzyme system. As a result, hormonal contraception is not considered adequate.

Exclusion Criteria:

- Patient with active AIDS-defining opportunistic infection in the 30 days prior to
baseline and that, in the opinion of the investigator, would preclude the patient
from participating in the study (See Appendix C).

- Patient has a weighted genotypic score for etravirine ≥3 . (See Appendix D)

- Patient has >3 mutations at 10, 20, 24, 32, 33, 36, 46, 47, 48, 50, 54, 73, 82, 84,
or 90 in protease or ≥1 of the following mutations in protease (I47A/V, V32I, or
L76V).

- History of active substance abuse.

- Pregnant at time of screening evaluation or breast-feeding.

- Patient, in the opinion of the investigator, is unlikely to be able to complete the
48-week dosing period and protocol evaluations and assessments or adhere to the study
drug regimen.

- Serious medical condition, such as diabetes, congestive heart failure, cardiomyopathy
or other cardiac dysfunction, which in the opinion of the investigator would
compromise the safety of the patient

- Malabsorption syndrome or other gastrointestinal dysfunction, which may interfere
with drug absorption or render the patient unable to take oral medication.

- Undergoing interferon therapy for HCV or anticipates undergoing therapy during the
course of this trial

- HBV co-infection

- Laboratory results within 30 days prior to the first dose of study medication:

- Hemoglobin concentration < 8.0 g/dL

- Absolute neutrophil count < 750 cells/mm3

- Platelet count <50,000 cells/ mm3

- Aminotransferase (AST, ALT) >3 times ULN

- Serum creatinine >1.5 times the Upper Limits of Normal (ULN)

- Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to entry,
or has an anticipated need for these agents within the study period.

- Immunomodulating agents, such as systemic corticosteroids, interleukins, or
interferon's within 4 weeks prior to study entry, or patients who have received an
HIV immunotherapeutic vaccine within 3 months prior to entry. Asthmatic patients
using inhaled corticosteroids are eligible for enrollment.

- Methadone therapy

- Foscarnet therapy or therapy with other agents with documented activity against HIV-1
in vitro.

- Taking astemizole, terfenadine, cisapride, oral midazolam, triazolam, flecainide,
pimozide, propafenone, St. John's Wort, lovastatin, simvastatin, and rifampin or
ergot derivatives.

- Allergy to any of the study drugs or any excipients therein.

- Patient requires inhaled or intranasal fluticasone.