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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. This study will test the safety and anti-HIV activity of eight different doses of the HIV entry inhibitor AMD11070 (also known as AMD070) in HIV infected patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: AIDS Clinical Trials Group

Criteria

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 prior to study entry, including HIV-associated opportunistic infections

• History of heart abnormalities. Patients with any repolarization delay (QTc interval of greater than 500 msec) or a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia) are also excluded.

• Drug or alcohol abuse or dependence or other medical or psychological condition that, in the opinion of the investigator, would interfere with the study or put participants at undue risk

• Chronic diarrhea, defined as having more than 3 stools/day for more than 4 weeks prior to study entry

• Pregnant or breastfeeding