Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens
NCT00052117
ABOUT THIS STUDY
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- HIV-infected male or female at least 18 years of age
- HIV RNA level >1000 copies/mL at screening
- Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors
- Adequate renal function
- Adequate hematological function
- Adequate liver function
- Women who are pregnant or lactating
- No previous experience with Kaletra
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Descriptive Information | ||||
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Brief Title ICMJE | Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens | |||
Official Title ICMJE | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study Of Capravirine (AG1549) In Combination With Kaletra (Trademark) and At Least 2 Nucleoside Reverse Transcriptase Inhibitors in Hiv-Infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors | |||
Brief Summary | This is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | HIV Infections | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 300 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | May 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Argentina, Brazil, Canada, France, Mexico, Netherlands, South Africa, Spain, United Kingdom, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00052117 | |||
Other Study ID Numbers ICMJE | A4311006 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | October 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |