Safety and Activity of the Oral HIV Entry Inhibitor AMD11070 in HIV Infected Patients

Inclusion Criteria: * HIV-1 infected * Have X4- or dual/mixed-tropic virus confirmed no more than 56 days prior to study entry * HIV-1 viral load of 5,000 copies/ml or more within 60 days prior to study entry * If female, willing to discontinue hormonal contraception 1 week prior to study entry * Willing to use acceptable forms of contraception Exclusion Criteria: * Antiretroviral treatment within 14 days prior to study entry * Other prescription medications, herbal supplements, or aspirin within 7 days prior to study entry. Patients taking medication for prophylaxis for Pneumocystis carinii pneumonia (PCP) are not excluded. Patients taking medications approved by protocol officials are not excluded, provided they have been on a stable dose for at least 14 days prior to study entry. * Nonsteroidal anti-inflammatory drugs (NSAIDS), over the counter medications, or other supplements (including multivitamins) within 1 day prior to study entry * Heavy exercise within 24 hours before study entry evaluations are done * Immunizations within 30 days prior to study entry * Radiation therapy, cytotoxic chemotherapeutic agents, or immunomodulatory agents within 30 days prior to study entry * Current use of some CYP substrates, inhibitors, or inducers. Use of CYP450 substrates is allowed, except for CYP2D6 and CYP2C8 substrates. * Current use of P-gp inducers or inhibitors * Allergy or sensitivity to study drug or its formulations * Active infection or acute illness within 14 days pri…