Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen - Tabular View

Tracking Information
First Received Date ^ICMJE	January 16, 2003
Last Updated Date	October 5, 2007
Start Date ^ICMJE	August 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: October 5, 2007)	The primary objective was to determine whether the addition of capravirine to a regimen of VIRACEPT and 2 new nucleoside reverse transcriptase inhibitors would provide a higher virologic response rate over 48 weeks when compared to a 3-drug regimen without capravirine in patients who had experienced virologic failure while on a nonnucleoside reverse transcriptase inhibitor regimen.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00051844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 5, 2007)	The safety and tolerability of 2 doses of capravirine. The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics The relationship of HIV resistance (genotype and phenotype) to virologic response. The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts The population pharmacokinetics of capravirine and VIRACEPT The pharmacokinetics of potential drug-drug interactions.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Human Immunodeficiency Virus
Intervention ^ICMJE	Drug: Capravirine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	150
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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) Exclusion Criteria: 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, France, Germany, Italy, South Africa, Spain

Administrative Information
NCT ID ^ICMJE	NCT00051844
Responsible Party
Study ID Numbers ^ICMJE	A4311002
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pfizer
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP