Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
NCT00051844
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Male or female at least 18 years old
- HIV RNA level >1000 copies/mL at screening
- CD4 >50 cells/uL at screening
- Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen
- Patient has adequate hematology tests (absolute neutrophil count >1000/uL, Platelets>75,000uL, hemoglobin 9g/L)
- Patient has adequate renal function (serum creatinine of <1.5 upper limit of normal)
- Patient has adequate liver function (AST, ALT, and bilirubin < 2.5 upper limit of normal)
- Previous use of protease inhibitors (except if patient has short duration of PI and
was switched for tolerability reasons when viral load was <50 copies) This exception
does not include Viracept
- Women who are pregnant or lactating
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Descriptive Information | |||
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Brief Title ICMJE | Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen | ||
Official Title ICMJE | A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen | ||
Brief Summary | This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible. | ||
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 | Human Immunodeficiency Virus | ||
Intervention ICMJE | Drug: Capravirine | ||
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 | ||
Actual Enrollment ICMJE | 179 | ||
Original Enrollment ICMJE | 150 | ||
Actual Study Completion Date ICMJE | November 2004 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
Sex/Gender ICMJE |
| ||
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 | France, Germany, Italy, South Africa, Spain, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00051844 | ||
Other Study ID Numbers ICMJE | A4311002 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Pfizer | ||
Verification Date | May 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |