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

Show 54 Study Locations

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 09, 2009