Trial record 7 of 20 for:
" July 18, 2007":" August 17, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
This study has been terminated.
Corroboration of supporting in vitro data
- Data successfully corroborated 2009
Information provided by (Responsible Party):
First received: July 18, 2007
Last updated: November 3, 2011
Last verified: November 2008
The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label, Multicenter, Mechanism Validation Study to Evaluate the Safety, Efficacy and Tolerability of KP-1461 as Monotherapy for 124 Days in Antiretroviral-experienced, HIV-1-infected Subjects
Primary Outcome Measures:
- To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the antiviral activity (eg., CD4 count, HIV RNA count) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2008 (Final data collection date for primary outcome measure)
Oral dosage, 1600 mg bid for 124 days
KP-1461 is a prodrug of KP-1212 triphosphate, a unique nucleoside that is incorporated into the HIV viral genome resulting in an accumulation of nucleic substitutions that interfere with viral replication. The study is designed to investigate the safety and antiviral activity for 124 days in antiretroviral-experienced HIV-1-infected subjects. By inducing additional mutagenic events in the viral genome, viral decay accelerators such as KP-1212 may force the virus to exceed the threshold of nonviability.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Asymptomatic HIV-1-infected individuals who are treatment-experienced and who have not been on ART for at least 16 weeks.
- Have documented prior non-suppressive ART including at least 1 NRTI, 1 NNRTI and 2 PIs; or have documented prior ART resistance to at least 1 NRTI, 1 NNRTI and 1 PI; AND in the opinion of the investigator, have few, if any, effective treatment options available.
- Have >2,500 copies/mL of HIV-1 RNA at screening.
- Have a stable CD4 cell count while off ART and >250 cells/mL at screening.
- Have no clinically significant findings on screening evaluations.
- Have a current or recent opportunistic infection that, in the opinion of the investigator, is not being controlled by medication.
- Have any condition that, in the opinion of the investigator, could compromise subject safety or adherence to the protocol.
- Have a documented positive test for hepatitis B surface antigen, or have received any antiviral therapy for hepatitis C <6 weeks prior to study drug administration.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504452
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 18, 2007
||November 3, 2011
||United States: Food and Drug Administration
Keywords provided by Koronis Pharmaceuticals.:
ClinicalTrials.gov processed this record on March 25, 2015
Viral decay acceleration