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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Beverly Hills, California, 90211 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Human Immunodeficiency Virus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- Patient has adequate liver function (AST, ALT, and bilirubin normal)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous use of protease inhibitors (except if patient has short duration of PI and
was switched for tolerability reasons when viral load was does not include Viracept

- Women who are pregnant or lactating

NCT00051844
Pfizer
Completed
Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen

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Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Human Immunodeficiency Virus
Drug: Capravirine
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
November 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   South Africa,   Spain,   United States
 
 
NCT00051844
A4311002
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Not Provided
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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