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

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Capravirine
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV, NNRTI Failure, HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
January 16, 2003
Last Updated
May 9, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00051844
Brief Title
Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, NNRTI Failure, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Capravirine
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
The safety and tolerability of 2 doses of capravirine.
Title
The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics
Title
The relationship of HIV resistance (genotype and phenotype) to virologic response.
Title
The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts
Title
The population pharmacokinetics of capravirine and VIRACEPT
Title
The pharmacokinetics of potential drug-drug interactions.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Pfizer Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Pfizer Investigational Site
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Pfizer Investigational Site
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339-3915
Country
United States
Facility Name
Pfizer Investigational Site
City
Jonesboro
State/Province
Georgia
ZIP/Postal Code
30236
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Pfizer Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Pfizer Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Pfizer Investigational Site
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1042
Country
United States
Facility Name
Pfizer Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97209
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Pfizer Investigational Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Pfizer Investigational Site
City
Lyon
State/Province
Cedex 02
ZIP/Postal Code
69288
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
State/Province
Cedex 10
ZIP/Postal Code
74575
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
State/Province
Cedex 3
ZIP/Postal Code
69437
Country
France
Facility Name
Pfizer Investigational Site
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Pfizer Investigational Site
City
Ulm
State/Province
Bavaria
ZIP/Postal Code
89070
Country
Germany
Facility Name
Pfizer Investigational Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
ZIP/Postal Code
02198
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
ZIP/Postal Code
2008
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pietermaritzburg
ZIP/Postal Code
3201
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pretoria North
ZIP/Postal Code
0182
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Soweto
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Baracaldo
State/Province
Bilbao, Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Pfizer Investigational Site
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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