Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens
A Double-Blind, Placebo-Controlled, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of KP-1461 in HIV+ Adults Who Have Failed Two or More Highly Active Antiretroviral Regimens (HAART)
1 other identifier
interventional
40
1 country
9
Brief Summary
The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461 given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple highly active antiretroviral therapy (HAART) regimens. Patients currently on HAART will be required to discontinue all HAART medications for up to 6 weeks after screening eligibility has been determined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 9, 2005
CompletedFirst Posted
Study publicly available on registry
August 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedJanuary 4, 2008
December 1, 2007
1.8 years
August 9, 2005
December 30, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- CD4 \> 100 cells/mm3
- Viral load 2,500 - 200,000 copies/mL
- Exposure to at least 2 different HAART regimens containing NRTI(s), NNRTI(s), and 2 PI(s), excluding Ritonavir, for a minimum of 4 months or documented resistance to at least 3 of the 4 classes of approved antiretroviral drugs.
- Few, if any, effective treatment options available
You may not qualify if:
- HBsAb (hepatitis B) positive serology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Bach and Godofsky
Bradenton, Florida, 34205, United States
University of Miami
Miami, Florida, 33146, United States
Triple O Medical Services
West Palm Beach, Florida, 33401, United States
Research Centers of Via Christi
Wichita, Kansas, 67214, United States
Institute of Human Virology, University of Maryland
Baltimore, Maryland, 21201, United States
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, 64106-1453, United States
St. Michael's Medical Center
Newark, New Jersey, 07102, United States
AIDS Community Research Initiative of America
New York, New York, 10018, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 9, 2005
First Posted
August 11, 2005
Study Start
August 1, 2005
Primary Completion
June 1, 2007
Last Updated
January 4, 2008
Record last verified: 2007-12