HIVNCT00247143
High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease
A study testing Kaletra (drug) in people with HIV and AIDS, run by Lampiris, Harry W., M.D. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of higher doses of lopinavir/ritonavir, in combination with other anti-HIV medications when administered as either the capsule or liquid formulations, among patients who have not had full viral suppression despite treatment with 3 classes… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Kaletra (drug)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to not given
- Phase
- Interventional
- 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
- Signed informed consent prior to trial participation.
- HIV-1 infected males or females at least 18 years of age.
- Weight > 60 kg and < 100 kg
- Acceptable laboratory screening values as defined in the exclusion criteria.
- Three class ARV experienced, including current PI regimen for at least 12 weeks, at least one other PI based regimen for at least 12 weeks, treatment with at least one NNRTI and with at least 2 nucleoside agents.
- Screening Virologic Phenotype demonstrating lopinavir phenotypic fold resistance between 10 and 80 (if patients have had Virologic Phenotype within 8 weeks of study screening this may be used as the qualifying lopinavir phenotypic fold resistance).
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- HIV-1 viral load 1000 copies/mL at screening.
- Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply:
- Total Cholesterol ≤ DAIDS Grade 3
- Total Triglycerides ≤ DAIDS Grade 3
- ALT and AST ≤DAIDS Grade 3).
- Any Grade GGT is acceptable.
- Any Grade CK is acceptable as long as there is no concurrent myopathy.
- All other laboratory test values ≤DAIDS Grade 2.
- Willingness to discontinue treatment with NNRTIs throughout 48 weeks of study participation (prior or current treatment with enfuvirtide is permitted).
- Acceptable medical history, as assessed by the investigator, with an unremarkable chest X-ray and ECG within 1 year of study participation.
- Willingness to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system (these are listed in the informed consent under the risks of lopinavir/ritonavir).
- A prior AIDS-defining event is acceptable as long as it has resolved or the patient has been on stable therapy for at least 12 weeks.
Who cannot join
- ARV medication naïve.
- Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 28 days
- Female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening or during the study,
- are breast feeding,
- are planning to become pregnant,
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- are not willing to a use barrier method of contraception, or
- require ethinyl estradiol administration.
- Prior high-dose LPV/RTV therapy (higher than recommended doses in package insert).
- Active diarrhea not controlled with antidiarrheal medications (not to exceed 3 bowel movements/day), malabsorption, or GI intolerance to lopinavir/ritonavir
- Use of investigational medications within 30 days before study entry or during the trial.
- Are receiving medications that are contraindicated with, or result in significant drug-drug interactions, with LPV and/or RTV (including, but not limited to triazolam, astemizole, ergot medications, cisapride, midazolam, bepridils, or rifampin).
- Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2).
- Active malignancy requiring chemotherapy or radiation.
- Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
- In the opinion of the investigator, likely survival of less than 6 months because of underlying disease.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Francisco VA Medical Center
San Francisco, California, 94121
Harry W. Lampiris, M.D.
About this study
Official title: Prospective Open Label Non-Comparative Study of the Safety, Efficacy and Tolerability of High Dose Ritonavir/Lopinavir Liquid in Salvage Therapy for PI Resistant HIV & a PK Equivalence Sub-Study of High Dose Ritonavir/Lopinavir Capsules
The purpose of this study is to evaluate the safety, tolerability and efficacy of higher doses of lopinavir/ritonavir, in combination with other anti-HIV medications when administered as either the capsule or liquid formulations, among patients who have not had full viral suppression despite treatment with 3 classes of HIV medications, and at least 2 prior courses of treatment with HIV protease inhibitors. In addition, pharmacokinetics of the active agents, lopinavir and ritonavir will be measured following administration of both the liquid and capsule formulations and compared.
Read the detailed description
This study is a safety, efficacy, and tolerability study of high dose kaletra in patients who have failed multiple antiretroviral regimens, including prior treatment with 3 classes of antiretroviral drugs (nucleoside/nucleotide analogues, non-nucleoside analogues, and at least one protease inhibitor based ARV regimen), in conjunction with optimized background therapy. Patients will initially be treated with high dose kaletra capsules and optimized background therapy for 4 weeks and then switched to equivalent doses of high dose kaletra liquid formulation for a total duration of therapy of 24 weeks. The primary endpoint of the study will be the average HIV RNA change from baseline through 24 weeks (HIV RNA AACUMB). Secondary endpoints will include the proportion achieving HIV RNA < 50 and HIV RNA < 400 copies/mL at 24 weeks. Changes in CD4 from baseline, change in LPV fold change in phenotypic resistance testing, changes in fasting metabolic parameters, assessment of safety at week 24 based upon hematology, chemistry, liver function, lipid levels, proportion of patients reporting adverse events and proportion of patients with SAEs, and demonstration of bioequivalence by 12 hour pharmacokinetic measurements.
- Being tested
- Kaletra (drug)
- Keywords
- Protease Inhibitor, Antiretroviral Agents, Treatment Experienced
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaletra (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and efficacy of high dose kaletra liquid and capsules in the treatment of highly antiretroviral experienced, protease inhibitor resistant HIV disease.
Secondary outcomes (1)
To compare traditional pharmacokinetic measures of the two formulations (kaletra liquid and kaletra capsules) in a subset of the patients included in the primary analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Lampiris, Harry W., M.D.
- Collaborators
- Abbott
- Investigators
- Harry W. Lampiris, M.D., Principal investigator, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247143
- Sponsor's protocol ID
- HWL-001
- Status last verified
- Sep 2006
- First submitted
- 28 Oct 2005
- Last updated
- 20 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open Label Non-Comparative Study of the Safety, Efficacy and Tolerability of High Dose Ritonavir/Lopinavir Liquid in Salvage Therapy for PI Resistant HIV & a PK Equivalence Sub-Study of High Dose Ritonavir/Lopinavir Capsules
- ClinicalTrials.gov ID
- NCT00247143
- Acronym / sponsor ID
- HWL-001
- Keywords
- Protease Inhibitor, Antiretroviral Agents, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Lampiris, Harry W., M.D.
- Collaborators
- Abbott
- Study start
- Oct 2005
- First posted
- 1 Nov 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 purpose of this study is to evaluate the safety, tolerability and efficacy of higher doses of lopinavir/ritonavir, in combination with other anti-HIV medications when administered as either the capsule or liquid formulations, among patients who have not had full viral suppression despite treatment with 3 classes of HIV medications, and at least 2 prior courses of treatment with HIV protease inhibitors. In addition, pharmacokinetics of the active agents, lopinavir and ritonavir will be measured following administration of both the liquid and capsule formulations and compared.
Detailed description
This study is a safety, efficacy, and tolerability study of high dose kaletra in patients who have failed multiple antiretroviral regimens, including prior treatment with 3 classes of antiretroviral drugs (nucleoside/nucleotide analogues, non-nucleoside analogues, and at least one protease inhibitor based ARV regimen), in conjunction with optimized background therapy. Patients will initially be treated with high dose kaletra capsules and optimized background therapy for 4 weeks and then switched to equivalent doses of high dose kaletra liquid formulation for a total duration of therapy of 24 weeks. The primary endpoint of the study will be the average HIV RNA change from baseline through 24 weeks (HIV RNA AACUMB). Secondary endpoints will include the proportion achieving HIV RNA < 50 and HIV RNA < 400 copies/mL at 24 weeks. Changes in CD4 from baseline, change in LPV fold change in phenotypic resistance testing, changes in fasting metabolic parameters, assessment of safety at week 24 based upon hematology, chemistry, liver function, lipid levels, proportion of patients reporting adverse events and proportion of patients with SAEs, and demonstration of bioequivalence by 12 hour pharmacokinetic measurements.
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 (18 listed)
- Signed informed consent prior to trial participation.
- HIV-1 infected males or females at least 18 years of age.
- Weight > 60 kg and < 100 kg
- Acceptable laboratory screening values as defined in the exclusion criteria.
- Three class ARV experienced, including current PI regimen for at least 12 weeks, at least one other PI based regimen for at least 12 weeks, treatment with at least one NNRTI and with at least 2 nucleoside agents.
Key exclusion criteria (16 listed)
- ARV medication naïve.
- Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the last 28 days
- Female patients of child-bearing potential who:
- Prior high-dose LPV/RTV therapy (higher than recommended doses in package insert).
- Active diarrhea not controlled with antidiarrheal medications (not to exceed 3 bowel movements/day), malabsorption, or GI intolerance to lopinavir/ritonavir
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 (drug) | Drug | – |
Primary outcome
To evaluate the safety and efficacy of high dose kaletra liquid and capsules in the treatment of highly antiretroviral experienced, protease inhibitor resistant HIV disease.
1 secondary outcome
To compare traditional pharmacokinetic measures of the two formulations (kaletra liquid and kaletra capsules) in a subset of the patients included in the primary analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2006.
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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.
Harry W. Lampiris, M.D. principal investigator
San Francisco Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaletra (drug) in people with HIV and AIDS, run by Lampiris, Harry W., M.D. at 1 site 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 18 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 20 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harry W. Lampiris, M.D. (415-379-5608, harry.lampiris@med.va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and efficacy of high dose kaletra liquid and capsules in the treatment of highly antiretroviral experienced, protease inhibitor resistant HIV disease.. 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 20 Sep 2006.