HIV InfectionsPhase 3NCT00508222
Kaletra Monotherapy in HIV/HCV Co-infected Subjects
A Phase 3 study testing Kaletra Tablets in people with HIV Infections, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
The study has been designed to test the hypothesis that in patients co-infected with HIV and HCV who exhibit maximal virologic suppression on a double class antiretroviral (ARV) regimen, including two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) or a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Kaletra Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 22 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2007to Apr 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has confirmed his or her willingness to participate in the study after being informed of all aspects of the trial that are relevant to his or her decision to participate, by signing and dating the IRB / IEC approved informed consent form.
- Subject is both HIV positive and HCV positive (must be viremic for HCV, not just antibody positive).
- Subject is 18 years of age or older.
- Subject must have an undetectable viral load (VL) less than 50 copies/ml for the last 6 months on HAART therapy.
- Subject must not be taking any medication that could interact with Kaletra® to enhance hepatic toxicity.
- Subject's serum AST and ALT levels must be \<5 times normal (grade 2 or less) at the start of the study.
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- Subject must not harbour viral strains that are resistant to Kaletra® at the start of the study.
- Subject has a Karnofsky Score 70 or greater.
- If female, subject must have a negative pregnancy test and agree to use, for the duration of the study, a barrier method of birth control that has a history of proven reliability as judged by the investigator.
- Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with Kaletra® (list will be in the protocol).
Who cannot join
- Subject has active hepatitis B (HbsAg +).
- Subject has a history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
- Subject has any of the following abnormal laboratory test results at screening:
- Hemoglobin 8.0 g/dL or more
- Absolute neutrophil count 500 cells/mL or more
- Platelet count 20,000/mL or more
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- ALT or AST 5x Upper Limit of Normal (ULN) or more
- Creatinine 1.5 x ULN or more
- Female subject is pregnant or lactating.
- Subject has received an investigational drug within 30 days prior to the initiation of study dosing.
- Subject exhibits viral strains that are resistant to lopinavir.
- Subject is receiving systemic chemotherapy.
- The subject, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital, General Campus
Ottawa, Ontario, K1H 8L6
University of British Columbia
Vancouver, British Columbia, V6Z 2C7
About this study
Official title: A Pilot, Prospective, Open-label Study to Evaluate the Safety and Efficacy of Kaletra® Monotherapy in HIV/HCV Co-infected Subjects.
The study has been designed to test the hypothesis that in patients co-infected with HIV and HCV who exhibit maximal virologic suppression on a double class antiretroviral (ARV) regimen, including two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) or a Protease Inhibitor (PI) (boosted or not with ritonavir), simplification of highly active antiretroviral therapy (HAART) to Kaletra® monotherapy will represent a viable strategy without any negative impact on the virologic control of HIV infection.
Read the detailed description
The primary purpose of this study is to determine how safe and effective the drug Kaletra® is in treating HIV when it is administered without any other antiretroviral drugs (monotherapy). Kaletra® is 2 protease inhibitors (lopinavir and ritonavir) combined in one dosage form.
Kaletra monotherapy is experimental and subjects eligible to the study are switching from a successful conventional triple therapy to an unproven experimental therapy.
Approximately 40 HIV/HCV coinfected participants, aged over 18 years will participate in this study.
- Conditions
- HIV Infections
- Being tested
- Kaletra Tablets
- Keywords
- HIV, HCV, HIV/HCV Co-infection, Kaletra Monotherapy, 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.
Kaletra TabletsDrug
Kaletra 800/200 OD
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to assess the safety and efficacy of Kaletra® (lopinavir/ritonavir) monotherapy in the treatment of patients co-infected with HIV and HCV.
patients on cART switched to Kaletra monotherapy an monitored for 48 weeks thereafter
Measured: 48 weeks
Secondary outcomes (2)
To investigate and compare the pharmacokinetics (PK) of Kaletra® monotherapy at steady-state between co-infected subjects with advanced liver fibrosis (stage 3-4) and those with minimal liver disease (stage 0-2)
PK measured at week 4 and 24
Measured: 24 weeks
To study compliance of subjects
adherence assessed at each study visit
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2011
- Study completionApr 2011
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.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Curtis Cooper, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508222
- Sponsor's protocol ID
- 2007217-01H
- Other IDs
- A06-321
- Status last verified
- May 2012
- First submitted
- 25 Jul 2007
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Prospective, Open-label Study to Evaluate the Safety and Efficacy of Kaletra® Monotherapy in HIV/HCV Co-infected Subjects.
- ClinicalTrials.gov ID
- NCT00508222
- Acronym / sponsor ID
- 2007217-01H
- Conditions
- HIV Infections
- Keywords
- HIV, HCV, HIV/HCV Co-infection, Kaletra Monotherapy, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jun 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 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 study has been designed to test the hypothesis that in patients co-infected with HIV and HCV who exhibit maximal virologic suppression on a double class antiretroviral (ARV) regimen, including two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) and a Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) or a Protease Inhibitor (PI) (boosted or not with ritonavir), simplification of highly active antiretroviral therapy (HAART) to Kaletra® monotherapy will represent a viable strategy without any negative impact on the virologic control of HIV infection.
Detailed description
The primary purpose of this study is to determine how safe and effective the drug Kaletra® is in treating HIV when it is administered without any other antiretroviral drugs (monotherapy). Kaletra® is 2 protease inhibitors (lopinavir and ritonavir) combined in one dosage form.
Kaletra monotherapy is experimental and subjects eligible to the study are switching from a successful conventional triple therapy to an unproven experimental therapy.
Approximately 40 HIV/HCV coinfected participants, aged over 18 years will participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has confirmed his or her willingness to participate in the study after being informed of all aspects of the trial that are relevant to his or her decision to participate, by signing and dating the IRB / IEC approved informed consent form.
- Subject is both HIV positive and HCV positive (must be viremic for HCV, not just antibody positive).
- Subject is 18 years of age or older.
- Subject must have an undetectable viral load (VL) less than 50 copies/ml for the last 6 months on HAART therapy.
- Subject must not be taking any medication that could interact with Kaletra® to enhance hepatic toxicity.
Key exclusion criteria (13 listed)
- Subject has active hepatitis B (HbsAg +).
- Subject has a history of substance abuse or psychiatric illness that could preclude compliance with the protocol.
- Subject has any of the following abnormal laboratory test results at screening:
- Female subject is pregnant or lactating.
- Subject has received an investigational drug within 30 days prior to the initiation of study dosing.
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 |
|---|---|---|
| Kaletra TabletsKaletra 800/200 OD | Drug | – |
Primary outcome
The primary objective of this study is to assess the safety and efficacy of Kaletra® (lopinavir/ritonavir) monotherapy in the treatment of patients co-infected with HIV and HCV.
Time frame: 48 weeks
patients on cART switched to Kaletra monotherapy an monitored for 48 weeks thereafter
2 secondary outcomes
To investigate and compare the pharmacokinetics (PK) of Kaletra® monotherapy at steady-state between co-infected subjects with advanced liver fibrosis (stage 3-4) and those with minimal liver disease (stage 0-2)
Time frame: 24 weeks
To study compliance of subjects
Time frame: 48 weeks
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 30 May 2012.
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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.
Curtis Cooper, MD principal investigator
OHRI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Kaletra Tablets in people with HIV Infections, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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 10 inclusion and 13 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 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
The primary objective of this study is to assess the safety and efficacy of Kaletra® (lopinavir/ritonavir) monotherapy in the treatment of patients co-infected with HIV and HCV. (time frame: 48 weeks). 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 30 May 2012.