Safety and Effectiveness of the Oral HIV Entry Inhibitor Vicriviroc in HIV Infected Patients

• Status: Completed
• Trial end date: 2011-01-01
• 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 effectiveness of three different doses of vicriviroc (formerly known as Schering D, SCH-D, or SCH 417690) in HIV infected patients.

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

Details

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

Criteria

Note: This study was closed to screening on 09/20/05 and to enrollment on 10/20/05.

Inclusion Criteria for Step 1:

• HIV infected

• Experiencing virologic failure on current ART regimen

• Current ART regimen contains ritonavir (100 to 800 mg/day) and has been stable for at least 8 weeks prior to study entry. If amprenavir or fosamprenavir is part of the regimen, 200 to 800 mg/day ritonavir must be used for at least 2 weeks prior to study entry.

• Experienced virologic failure on at least one ART regimen containing 3 or more drugs prior to current failing regimen

• CD4 count of 50 cells/mm3 or more within 6 weeks prior to study entry

• HIV viral load of 5,000 copies/ml or more within 6 weeks prior to study entry

• HIV strain of R5-only phenotype within 6 weeks prior to study entry

• Willing to use acceptable forms of contraception

• Able and willing to adhere to study dose and visit schedules

Inclusion Criteria for Step 2:

• HIV viral load not suppressed by at least 1log10 below baseline viral load by Week 16 or after

• QTc interval on EKG less than 500 msec, and less than 60 msec increase from baseline within 14 days of Step 2 entry

Inclusion Criteria for Step 3:

• Use of vicriviroc in Step 1 or 2 of this study or the Schering rollover study. Participants who are currently not taking vicriviroc are eligible.

Exclusion Criteria for Step 1:

• Hepatitis C antibody and RNA positive

• Hepatitis B surface antigen positive

• Efavirenz or nevirapine use within 8 weeks of study entry

• Vaccination within 2 weeks prior to study screening

• Investigational agents within 30 days prior to study entry

• Systemic cancer chemotherapy or other systemic cytotoxic agents within 30 days prior to study entry

• Immunosuppressants within 30 days prior to study entry. Systemic corticosteroids at replacement doses (10 mg/day prednisone or less) are not excluded.

• Immunomodulators within 30 days prior to study entry

• Considered at risk for seizure: history of seizure, recent history of head trauma with loss of consciousness, central nervous system (CNS) tumors, or other CNS problems that, in the opinion of the investigator, pose increased risk for seizure

• Medications to prevent seizures or with the potential to cause seizures within 30 days prior to study entry

• Allergy to SCH 417690 or its components

• Alcohol or drug abuse that, in the opinion of the investigator, would interfere with the study

• Serious illness requiring systemic treatment or hospitalization. A patient who is clinically stable on therapy is not excluded.

• Any clinically significant disease or condition that, in the opinion of the investigator, may interfere with the study

• Require certain medications

• Pregnancy or breastfeeding

Exclusion Criteria for Step 2:

• Have X4 or X4/R5 tropic virus, as determined by the HIV-1 coreceptor tropism assay

• Intend to use efavirenz or nevirapine in background ART regimen

• Allergy to vicriviroc or its formulations

• Pregnancy