Clinical trial NCT00051844: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Human Immunodeficiency Virus
Keywords: HIV
NNRTI Failure
HIV Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-01-20
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
measure: 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 outcomes:
measure: The safety and tolerability of 2 doses of capravirine.
measure: The difference between 2 doses of capravirine in terms of tolerability, efficacy, and pharmacokinetics
measure: The relationship of HIV resistance (genotype and phenotype) to virologic response.
measure: The immunologic response as determined by CD4 and CD8 absolute lymphocyte counts
measure: The population pharmacokinetics of capravirine and VIRACEPT
measure: The pharmacokinetics of potential drug-drug interactions.
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: West Hollywood
country: United States
facility: Pfizer Investigational Site
state: California
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Safety Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Tucker
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Huntersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Galveston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lyon
country: France
facility: Pfizer Investigational Site
state: Cedex 02
city: Paris
country: France
facility: Pfizer Investigational Site
state: Cedex 10
city: Lyon
country: France
facility: Pfizer Investigational Site
state: Cedex 3
city: Nantes
country: France
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
state: Bavaria
city: Brescia
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Pietermaritzburg
country: South Africa
facility: Pfizer Investigational Site
city: Port Elizabeth
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria North
country: South Africa
facility: Pfizer Investigational Site
city: Soweto
country: South Africa
facility: Pfizer Investigational Site
city: Baracaldo
country: Spain
facility: Pfizer Investigational Site
state: Bilbao, Vizcaya
city: Bilbao
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
Study officials:
References: