Clinical trial NCT00129194: Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
Treatment Experienced
Lead sponsor: Koronis Pharmaceuticals.
Sponsor class: INDUSTRY
First posted: 2005-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Bach and Godofsky
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Medical Services
state: Florida
city: Wichita
country: United States
facility: Research Centers of Via Christi
state: Kansas
city: Baltimore
country: United States
facility: Institute of Human Virology, University of Maryland
state: Maryland
city: Kansas City
country: United States
facility: Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
state: Missouri
city: Newark
country: United States
facility: St. Michael's Medical Center
state: New Jersey
city: New York
country: United States
facility: AIDS Community Research Initiative of America
state: New York
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
Study officials:
References: