Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients

Inclusion criteria

Asymptomatic HIV-1 infected individuals that are treatmen naïve (ie less than 2 weeks prior ARV exposure) or treatment experienced subjects who are not currently on HAART and have not received any ARVs for 3 months prior to Screening.

• Males between 18 years and 65 years of age, utilizing adequate contraceptive methods.
• Post menopausal or surgically sterile females between 18 years and 65 years of age. Women of childbearing potential, utilizing adequate contraceptive methods.
• CD4-lymphocyte count >350 cells/mm3
• HIV-1 RNA copies/ml > 10,000.
• HIV-1 is CCR5 tropic virus only.
• CCR5 antagonist treatment naive.
• BMI > 16 to < 32 kg/m2.
• Have no clinically significant findings on screening evaluations, which in the opinion of the Investigator would interfere with the subject's ability to comply with the protocol.
• Able to comprehend and willing to sign an Informed Consent Form.

Exclusion criteria

• Current or recent (<30 days) opportunistic infection.
• Presence of CXCR4- or dual-tropic HIV-1 virus at Screening or Baseline assessments.
• Subjects with chronic renal insufficiency
• Personal history of cardiac diseases.
• History or presence of an abnormal ECG.
• History of unstable ischemic heart disease or uncontrolled hypertension.
• History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
• Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents and have not recovered from side effects.
• Current treatment or treatment within 30 days or 5 half-lives with another investigational medication or current enrollment in another investigational drug protocol.
• Subjects with unstable medical condition (s), which , in the opinion of the Investigator would compromise their participation in the trial