Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens - Full Text View

Sponsored by:	Koronis Pharmaceuticals.
Information provided by:	Koronis Pharmaceuticals.
ClinicalTrials.gov Identifier:	NCT00129194

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: KP-1461	Phase I

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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)

Further study details as provided by Koronis Pharmaceuticals.:

Estimated Enrollment:	40
Study Start Date:	August 2005
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed Description:

KP-1461 is a carbamate prodrug of the active nucleoside, KP-1212. KP-1212 is incorporated into the proviral DNA. After multiple rounds of replication, KP-1212 increases the high inherent mutation rate of HIV beyond the threshold of viability, a process called "viral decay acceleration". KP-1212 is unique from conventional nucleoside reverse transcriptase inhibitors in that it inserts mutations randomly across the entire 10,000 nucleotide HIV genome and does not exert selective pressure by targeting a specific viral or cellular process, thus potentially avoiding drug resistance.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

HBsAb (hepatitis B) positive serology

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129194

Locations

United States, Florida
Bach and Godofsky
Bradenton, Florida, United States, 34205
University of Miami
Miami, Florida, United States, 33146
Triple O Medical Services
West Palm Beach, Florida, United States, 33401
United States, Kansas
Research Centers of Via Christi
Wichita, Kansas, United States, 67214
United States, Maryland
Institute of Human Virology, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Missouri
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, United States, 64106-1453
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New York
AIDS Community Research Initiative of America
New York, New York, United States, 10018
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605

Sponsors and Collaborators

Koronis Pharmaceuticals.

More Information

Study ID Numbers:	KP-1461-102
Study First Received:	August 9, 2005
Last Updated:	December 30, 2007
ClinicalTrials.gov Identifier:	NCT00129194
Health Authority:	United States: Food and Drug Administration

Keywords provided by Koronis Pharmaceuticals.:

HIV
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009