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Study of KP-1461 for the Trea...

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

Last Updated: 2008-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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KP-1461

Intervention Type DRUG

Eligibility Criteria

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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