Pilot Assessment of Lopinavir/Ritonavir and Maraviroc (PALM)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Rodwick, Barry M., M.D..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Rodwick, Barry M., M.D.
Collaborator:
Abbott
Information provided by:
Rodwick, Barry M., M.D.
ClinicalTrials.gov Identifier:
NCT00981318
First received: September 19, 2009
Last updated: February 22, 2010
Last verified: February 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 19, 2009 | ||||||||
| Last Updated Date | February 22, 2010 | ||||||||
| Start Date ICMJE | December 2009 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Virologic response defined as viral load reduction of >/= 1 log [ Time Frame: 48 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00981318 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pilot Assessment of Lopinavir/Ritonavir and Maraviroc | ||||||||
| Official Title ICMJE | Pilot Assessment of Lopinavir/Ritonavir and Maraviroc in Experienced Patients | ||||||||
| Brief Summary | This is a study to assess the response of lopinavir/ritonavir plus maraviroc (with no nucleoside medications) in HIV patients failing their initial antiviral therapy. |
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| Detailed Description | As long-term toxicity to many of the nucleoside medications have become known, interest has increased in treatment regimens that do not use these medications. This study is to assess the response of one such "nucleoside-sparing" therapy in patients who are showing failure to their initial nucleoside-containing treatment regimen. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: lopinavir/ritonavir plus maraviroc
lopinavir/ritonavir 400/100 mg bid plus maraviroc 150 mg bid
Other Names:
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 25 | ||||||||
| Estimated Completion Date | July 2011 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00981318 | ||||||||
| Other Study ID Numbers ICMJE | Rodwick01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Barry M. Rodwick, M. D. | ||||||||
| Study Sponsor ICMJE | Rodwick, Barry M., M.D. | ||||||||
| Collaborators ICMJE | Abbott | ||||||||
| Investigators ICMJE |
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| Information Provided By | Rodwick, Barry M., M.D. | ||||||||
| Verification Date | February 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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