A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules - NCT00281606-95128 (Clinical Trial 136360)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy136360.aspx
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| City: |
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San Jose |
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State:
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CA |
| Zip Code: |
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95128 |
| Conditions: |
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HIV Infection |
| Purpose: |
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Guidelines have continued to list lopinavir/ritonavir as a preferred protease
inhibitor-containing regimen for HIV-infected individuals. There has recently been
increasing interest in once daily therapy. While lopinavir/ritonavir has recently been
approved as a once daily therapy it was associated with considerable diarrhea in those
treated with soft gel capsules. It is the hope that alternative formulations of
lopinavir/ritonavir may provide similar pharmacokinetics with improved tolerability. This
includes the possibility of using liquid or newly released tablets. This study will treat
people tolerating their current regimen with up to four weeks of each formulation with
several assessments of pharmacokinetics and tolerability for each.
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| Study summary: |
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This study is designed to assess the tolerability of different forms (liquid, capsules or
tablets) of lopinavir/ritonavir given once-daily as part of combination therapy for HIV
infection. Study subjects will be those tolerating a stable regimen of HIV medications with
undetectable levels of HIV in their blood. They will be assigned by chance to receive once
daily liquid or soft gel capsules of lopinavir/ritonavir for up to four weeks. At that time
they will receive the alternative formulation for up to four weeks. They will then be given
once daily lopinavir/ritonavir in the recently released tablet formulation. After up to
four weeks of each of these formulations several assessments will be made of the overall
tolerability of the drug. After four weeks of tablets they will be allowed to take whatever
regimen they want and will be followed for an additional 36 weeks for a total duration of
study of up to 48 weeks. The pharmacokinetics of each formulation of lopinavir/ritonavir
given once daily will also be assessed in a subset of study subjects. |
| Criteria: |
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Inclusion Criteria:
- Ability and willingness of subject or legal guardian/representative to give written
informed consent.
- HIV-1 infected.
- At least 18 years of age
- Have the last two HIV-1 RNA measurements performed prior to screening be <50 or 75
copies/mL within the last 180 days, as well as at the time of screening.
- No evidence of primary PI mutations (defined by IAS-USA) documented on previous
resistance testing, if ever performed and available, or suggested to be present by
previous treatment history.
- Laboratory values:
- Absolute neutrophil count (ANC) >500/mm3.
- -Hemoglobin >7.0 g/dL.
- platelet count >50,000/mm3.
- AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 X ULN.
- Total bilirubin <2.5 x ULN, unless on IDV or ATV in which case must be <1.5 x
ULN of direct bilirubin.
- Calculated creatinine clearance >50 mL/min as estimated by the Cockcroft-Gault
equation
- For women of reproductive potential, negative serum or urine pregnancy test within 7
days prior to initiating study medications. If participating in sexual activity that
could lead to pregnancy, female study subjects must use two forms of contraception,
one of which must be a barrier method. All subjects must continue to use
contraception for 6 weeks after stopping the study medications.
- Willingness to take an alcohol containing product.
- Karnofsky performance score >70.
Exclusion Criteria:
- Pregnancy or breast-feeding
- Greater than Grade 1 diarrhea or nausea (as defined by protocol)
- Use of a NNRTI within 12 weeks of screening
- Use of antimotility or antiemetics during the 14 days prior to screening
- Use of any of the prohibited medications (defined by protocol) within 30 days of
study entry.
- Need to continue the use of prohibited or select precautionary medications (defined
by protocol)
- Known hypersensitivity to lopinavir/ritonavir
- Active drug or alcohol use or dependence which, in the Investigator’s opinion, may
interfere with adherence to study requirements or endanger subject’s health while on
the study
- Serious illness requiring systemic treatment and/or hospitalization until subject
either completes therapy or is clinically stable on therapy, in the opinion of the
investigator, for at least 30 days prior to study entry.
- Acute therapy for serious infection or other serious medical illnesses (in the
judgment of the site investigator) requiring systemic treatment and/or
hospitalization within 14 days prior to study entry.
- Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV-1
vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days
prior to study entry |
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| Study is available at: |
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Santa Clara Valley Medical Center
San Jose, CA 95128
United States |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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