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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00051844

Purpose

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.

Condition	Intervention	Phase
Human Immunodeficiency Virus	Drug: Capravirine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Capravirine

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	150
Study Start Date:	August 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051844

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Locations

United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
Pfizer Investigational Site
Long Beach, California, United States, 90813
Pfizer Investigational Site
San Francisco, California, United States, 94115
Pfizer Investigational Site
West Hollywood, California, United States, 90069
Pfizer Investigational Site
Newport Beach, California, United States, 92663
Pfizer Investigational Site
San Francisco, California, United States, 94121
United States, Florida
Pfizer Investigational Site
Safety Harbor, Florida, United States, 34695
Pfizer Investigational Site
Tampa, Florida, United States, 33602
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33311
Pfizer Investigational Site
Miami, Florida, United States, 33137
United States, Georgia
Pfizer Investigational Site
Jonesboro, Georgia, United States, 30236
Pfizer Investigational Site
Tucker, Georgia, United States, 30084
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339-3915
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67214
United States, Mississippi
Pfizer Investigational Site
Jackson, Mississippi, United States, 39202
United States, New York
Pfizer Investigational Site
Stony Brook, New York, United States, 11794
Pfizer Investigational Site
Brooklyn, New York, United States, 11203
Pfizer Investigational Site
New York, New York, United States, 10003
United States, North Carolina
Pfizer Investigational Site
Huntersville, North Carolina, United States, 28078
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27157-1042
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44304
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97209
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Houston, Texas, United States, 77009
Pfizer Investigational Site
Galveston, Texas, United States, 77555
Pfizer Investigational Site
Dallas, Texas, United States, 75246
France
Pfizer Investigational Site
Nantes, France, 44035
France, Cedex 02
Pfizer Investigational Site
Lyon, Cedex 02, France, 69288
France, Cedex 10
Pfizer Investigational Site
Paris, Cedex 10, France, 74575
France, Cedex 3
Pfizer Investigational Site
Lyon, Cedex 3, France, 69437
Germany, Bavaria
Pfizer Investigational Site
Ulm, Bavaria, Germany, 89070
Italy
Pfizer Investigational Site
Milano, Italy, 20127
Pfizer Investigational Site
Brescia, Italy, 25123
Pfizer Investigational Site
Milano, Italy, 20157
Pfizer Investigational Site
Roma, Italy, 00149
South Africa
Pfizer Investigational Site
Johannesburg, South Africa, 2008
Pfizer Investigational Site
Cape Town, South Africa, 7405
Pfizer Investigational Site
Johannesburg, South Africa, 2193
Pfizer Investigational Site
CAPE TOWN, South Africa, 7925
Pfizer Investigational Site
Soweto, South Africa, 2013
Pfizer Investigational Site
Port Elizabeth, South Africa, 6001
Pfizer Investigational Site
Pietermaritzburg, South Africa, 3201
Pfizer Investigational Site
Johannesburg, South Africa, 02198
Pfizer Investigational Site
Pretoria North, South Africa, 0182
Pfizer Investigational Site
Cape Town, South Africa, 7925
Spain
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Cordoba, Spain, 14004
Spain, Bilbao, Vizcaya
Pfizer Investigational Site
Baracaldo, Bilbao, Vizcaya, Spain, 48903
Spain, Vizcaya
Pfizer Investigational Site
Bilbao, Vizcaya, Spain, 48903

Sponsors and Collaborators

Pfizer

More Information

No publications provided

Study ID Numbers:	A4311002
Study First Received:	January 16, 2003
Last Updated:	October 5, 2007
ClinicalTrials.gov Identifier:	NCT00051844 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

HIV
NNRTI Failure
HIV Infections

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 25, 2009