HIV InfectionsPhase 2NCT00504452
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
A Phase 2 study testing KP-1461 in people with HIV Infections, run by Koronis Pharmaceuticals. at 31 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- KP-1461
- Type of treatment
- Pill or oral medicine
- How many people
- 27 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Jul 2007to Jun 2009
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States30 sites
Albany Medical College
Albany, New York, 12208
CARE-ID
Annandale, Virginia, 22003
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Institute of Human Virology, University of Maryland
Baltimore, Maryland, 21201
Community Research Initiative of New England
Boston, Massachusetts, 02215
Northstar Medical Center
Chicago, Illinois, 60657
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Charlton Methodist Hospital
Dallas, Texas, 75204
Duke University Medical Center
Durham, North Carolina, 27710
Comprehensive Care Center -- HIV Clinical Research
Fort Lauderdale, Florida, 33311
University of Texas Health Science Center
Houston, Texas, 77030
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, 64106
Health for Life Clinic
Little Rock, Arkansas, 72207
Living Hope Clinical Foundation
Long Beach, California, 90813
Light Source Medical/U. of Southern California
Los Angeles, California, 90036
AIDS Community Research Initiative of America
New York, New York, 10018
Mount Sinai Medical Center
New York, New York, 10029
St. Michael's Medical Center
Newark, New Jersey, 07102
Wohlfeiler, Piperato and Associates, LLC
North Miami Beach, Florida, 33169
Orlando Immunology Center
Orlando, Florida, 32803
Thomas Jefferson University, Division of Infectious Disease
Philadelphia, Pennsylvania, 19107
ACTU at CARES/UC Davis
Sacramento, California, 95817
UCSD Antiviral Research Center
San Diego, California, 92103
Quest Clinical Research
San Francisco, California, 94115
Southwest CARE Center
Santa Fe, New Mexico, 87505
University of Washington AIDS Clinical Trials Unit
Seattle, Washington, 98104
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009
Whitman-Walker Clinic
Washington D.C., District of Columbia, 20009
University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi
Wichita, Kansas, 67214
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- KP-1461
- Keywords
- HIV, viral, Viral decay acceleration, ART, HAART, 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
Oral dosage, 1600 mg bid for 124 days
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.
Measured: 124 days
Secondary outcomes (1)
To evaluate the antiviral activity (eg., CD4 count, HIV RNA count) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.
Measured: 124 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2008
- Study completionJun 2009
Why it stopped: Corroboration of supporting in vitro data \- Data successfully corroborated 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koronis Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504452
- Sponsor's protocol ID
- KP-1461-201
- Status last verified
- Nov 2008
- First submitted
- 18 Jul 2007
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00504452
- Acronym / sponsor ID
- KP-1461-201
- Conditions
- HIV Infections
- Keywords
- HIV, viral, Viral decay acceleration, ART, HAART, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corroboration of supporting in vitro data \- Data successfully corroborated 2009
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Koronis Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Jul 2007 (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 investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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-1461Oral dosage, 1600 mg bid for 124 days | Drug | – |
Primary outcome
To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.
Time frame: 124 days
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Corroboration of supporting in vitro data \- Data successfully corroborated 2009). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
- Results on drug activity in patients who completed treatmentLink provided by the sponsor.
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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.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KP-1461 in people with HIV Infections, run by Koronis Pharmaceuticals. at 31 sites in 2 countries.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Corroboration of supporting in vitro data \- Data successfully corroborated 2009). Results are not available in the source record.
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.
What does the primary outcome measure?
To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. (time frame: 124 days). It is what the study was designed to measure, not a finding.
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 7 Nov 2011.