| |
Ritonavir-Boosted GS-9137 Vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART. phase II study
|
| |
| |
This study is currently recruiting patients.
Verified by Gilead Sciences February 2006 Sponsored by: Gilead Sciences
Purpose: The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.
Study Design:
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title: Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) Vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART. Further study details as provided by Gilead Sciences:
Expected Total Enrollment: 200
Study start: February 2006
Eligibility Ages
18 Years - 65 Years,
Inclusion Criteria:
- HIV RNA greater than or equal to 1000 c/mL.
- Failed/Failing protease inhibitor based antiretroviral therapy.
- Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.
- Negative Serum Pregnancy Test.
- GFR by Cockcroft Gault greater than or equal to 80 mL/min.
- AST & ALT less than or equal to 2.5x ULN.
- Total Bilirubin less than or equal to 1.5 mg/dL.
- Albumin greater than 3.5 mg/dL.
- Prothrombin Time INR 1.0-1.4
- Platelets greater than or equal to 50,000.
- Hemoglobin greater than or equal to 8.0 mg/dL.
- Absolute Neutrophil Count greater than or equal to 1000.
Exclusion Criteria:
- New AIDS defining condition within 30 days of baseline.
- Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).
- Ascites or encephalopathy.
- Breast Feeding.
- Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).
Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00298350
John Sayre, RN 650-574-3000 jsayre@gilead.com
Arizona
Phoenix, Arizona, 85006, United States; Not yet recruiting
Arkansas
Little Rock, Arkansas, 72207, United States; Recruiting
California
San Francisco, California, 94110, United States; Not yet recruiting
San Diego, California, 92103, United States; Not yet recruiting
Oakland, California, 94609, United States; Not yet recruiting
Torrance, California, 90502, United States; Not yet recruiting
Beverley Hills, California, 90211, United States; Not yet recruiting
Los Angeles, California, 90033, United States; Recruiting
Sunnyvale, California, 94086, United States; Not yet recruiting
Newport Beach, California, 92663, United States; Recruiting
Long Beach, California, 60813, United States; Recruiting
Fountain Valley, California, 92708, United States; Not yet recruiting
Stanford, California, 94305-5107, United States; Not yet recruiting
Colorado
Denver, Colorado, 80220, United States; Recruiting
Connecticut
Norwalk, Connecticut, 06851, United States; Not yet recruiting
District of Columbia
Washington, District of Columbia, 20037, United States; Recruiting
Florida
Atlantis, Florida, 33462, United States; Recruiting
Miami, Florida, 33136, United States; Recruiting
North Palm Beach, Florida, 33408, United States; Not yet recruiting
Fort Lauderdale, Florida, 33308, United States; Not yet recruiting
Tampa, Florida, 33602, United States; Not yet recruiting
Vero Beach, Florida, 32960, United States; Not yet recruiting
Sarasota, Florida, 34239, United States; Recruiting
North Miami Beach, Florida, 33169, United States; Not yet recruiting
Georgia
Decatur, Georgia, 30033, United States; Not yet recruiting
Macon, Georgia, 31201, United States; Not yet recruiting
Illinois
Chicago, Illinois, 60657, United States; Recruiting
Maryland
Baltimore, Maryland, 21205, United States; Not yet recruiting
Massachusetts
Boston, Massachusetts, 02215-3318, United States; Not yet recruiting
Springfield, Massachusetts, 01107, United States; Not yet recruiting
Michigan
Detroit, Michigan, 48202, United States; Not yet recruiting
Missouri
St. Louis, Missouri, 63108, United States; Not yet recruiting
Nevada
Henderson, Nevada, 89074, United States; Not yet recruiting
New Jersey
Hillsborough, New Jersey, 08844, United States; Not yet recruiting
New Mexico
Santa Fe, New Mexico, 87505, United States; Not yet recruiting
New York
New York City, New York, 10016, United States; Not yet recruiting
Albany, New York, 12208-3479, United States; Not yet recruiting
Manhasset, New York, 11030, United States; Not yet recruiting
North Carolina
Huntersville, North Carolina, 28078, United States; Not yet recruiting
Winston-Salem, North Carolina, 27157-1042, United States; Not yet recruiting
Ohio
Cleveland, Ohio, 44106, United States; Not yet recruiting
Pennsylvania
Philadelphia, Pennsylvania, 19107, United States; Not yet recruiting
Hershey, Pennsylvania, 17033, United States; Not yet recruiting
South Carolina
Columbia, South Carolina, 29206, United States; Not yet recruiting
Texas
Houston, Texas, 77030, United States; Not yet recruiting
Dallas, Texas, 75204, United States; Not yet recruiting
Virginia
Hampton, Virginia, 23666, United States; Not yet recruiting
Annandale, Virginia, 22003-7313, United States; Recruiting
Washington
Seattle, Washington, 98101, United States; Not yet recruiting
Tacoma, Washington, 98405, United States; Not yet recruiting
Wisconsin
Milwaukee, Wisconsin, 53226, United States; Not yet recruiting
Puerto Rico
San Juan, 00921-3201, Puerto Rico; Not yet recruiting
Santurce, 00909, Puerto Rico; Not yet recruiting
|
|
| |
| |
|
|
|
