HIV InfectionsPhase 1NCT00129194
Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens
A Phase 1 study testing KP-1461 in people with HIV Infections, run by Koronis Pharmaceuticals. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- KP-1461
- How many people
- 40 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2005to Jun 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- HBsAb (hepatitis B) positive serology
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Institute of Human Virology, University of Maryland
Baltimore, Maryland, 21201
Bach and Godofsky
Bradenton, Florida, 34205
Greenville Hospital System
Greenville, South Carolina, 29605
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, 64106-1453
University of Miami
Miami, Florida, 33146
AIDS Community Research Initiative of America
New York, New York, 10018
St. Michael's Medical Center
Newark, New Jersey, 07102
Triple O Medical Services
West Palm Beach, Florida, 33401
Research Centers of Via Christi
Wichita, Kansas, 67214
About this 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)
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- KP-1461
- Keywords
- HIV, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KP-1461Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koronis Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129194
- Sponsor's protocol ID
- KP-1461-102
- Status last verified
- Dec 2007
- First submitted
- 9 Aug 2005
- Last updated
- 4 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00129194
- Acronym / sponsor ID
- KP-1461-102
- Conditions
- HIV Infections
- Keywords
- HIV, Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Koronis Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jun 2007 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- HBsAb (hepatitis B) positive serology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KP-1461 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KP-1461 in people with HIV Infections, run by Koronis Pharmaceuticals. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2008.