The primary purpose of the study is to assess the safety of KP-1461 given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple Highly Active Antiretrovrial Regimens (HAART). Patients will be required to discontinue all HAART medications for up to 6 weeks after screening eligibility requirements have been determined.

Condition	Intervention	Phase
HIV	Drug: KP-1461	Phase I

Further Study Details: 

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• CD4 > 100 cells
• Viral Load 2,500 - 50,000 copies
• Exposure to at least 2 diferrent HAART regimens lasting at least 4 months
• Few if any effective treatment options available

Exclusion Criteria:

• HCV or HBsAb positive serology

Please refer to this study by ClinicalTrials.gov identifier  NCT00129194

Charles D Preston, B.S.      240-403-2275    bpreston@summitdrug.com

California
      AIDS ReSearch Alliance, West Hollywood,  California,  United States; Not yet recruiting
      AIDS Healthcare Foundation, Beverly Hills,  California,  United States; Not yet recruiting
Florida
      Bach and Godofsky, Bradenton,  Florida,  34205,  United States; Recruiting
      University of Miami, Miami,  Florida,  33146,  United States; Recruiting
Kansas
      Research Centers of Via Christi, Wichita,  Kansas,  67214,  United States; Recruiting
New Jersey
      St. Michael''''s Medical Center, Newark,  New Jersey,  07102,  United States; Recruiting
South Carolina
      Greenville Hospital System, Greenville,  South Carolina,  29605,  United States; Recruiting

Study chairs or principal investigators

Ellen Cooper, M.D.,  Study Director,  President - Summit Drug Development Services   

Study ID Numbers:  KP-1461-102
Last Updated:  August 10, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00129194
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23