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

NCT00051844 | Completed Phase 2

• 1 other identifier: A4311002
• Study Type: interventional
• Target: 179
• Locations: 6 countries
• Sites: 52

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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV; NNRTI Failure; HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Interventions

Capravirine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (52)

Pfizer Investigational Site

Beverly Hills, California, 90211, United States

Location

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Long Beach, California, 90813, United States

Location

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Newport Beach, California, 92663, United States

Location

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San Francisco, California, 94115, United States

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San Francisco, California, 94121, United States

Location

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West Hollywood, California, 90069, United States

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Fort Lauderdale, Florida, 33311, United States

Location

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Miami, Florida, 33137, United States

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Safety Harbor, Florida, 34695, United States

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Tampa, Florida, 33602, United States

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Atlanta, Georgia, 30339-3915, United States

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Jonesboro, Georgia, 30236, United States

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Tucker, Georgia, 30084, United States

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Chicago, Illinois, 60611, United States

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Wichita, Kansas, 67214, United States

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Jackson, Mississippi, 39202, United States

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Brooklyn, New York, 11203, United States

Location

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New York, New York, 10003, United States

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Stony Brook, New York, 11794, United States

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Huntersville, North Carolina, 28078, United States

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Winston-Salem, North Carolina, 27157-1042, United States

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Akron, Ohio, 44304, United States

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Cincinnati, Ohio, 45267, United States

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Portland, Oregon, 97209, United States

Location

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Portland, Oregon, 97210, United States

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Philadelphia, Pennsylvania, 19107, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75246, United States

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Galveston, Texas, 77555, United States

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Houston, Texas, 77009, United States

Location

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Lyon, Cedex 02, 69288, France

Location

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Paris, Cedex 10, 74575, France

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Lyon, Cedex 3, 69437, France

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Nantes, 44035, France

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Ulm, Bavaria, 89070, Germany

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Brescia, 25123, Italy

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Milan, 20127, Italy

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Milan, 20157, Italy

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Roma, 00149, Italy

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Cape Town, 7405, South Africa

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Cape Town, 7925, South Africa

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Johannesburg, 02198, South Africa

Location

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Johannesburg, 2008, South Africa

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Johannesburg, 2193, South Africa

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Pietermaritzburg, 3201, South Africa

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Port Elizabeth, 6001, South Africa

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Pretoria North, 0182, South Africa

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Soweto, 2013, South Africa

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Barakaldo, Bilbao, Vizcaya, 48903, Spain

Location

Pfizer Investigational Site

Bilbao, Vizcaya, 48903, Spain

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Pfizer Investigational Site

Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

capravirine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 16, 2003
• First Posted: January 20, 2003
• Study Start: August 1, 2002
• Study Completion: November 1, 2004
• Last Updated: May 10, 2011

Record last verified: 2011-05

Locations

ES (4); ZA (9); FR (4); DE (1); IT (4); US (30)