Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
Information provided by (Responsible Party)
First received: February 28, 2006
Last updated: July 28, 2008
Last Verified: July 2008
History of Changes
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.
Human Immunodeficiency Virus
Drug : GS-9137 - A Novel HIV-1 Integrase Inhibitor
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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:
|Study Start Date:||February 2006|
|Study Completion Date:||July 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
|Ages Eligible for Study:||18 Years to 65 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298350
Locations Show More
|United States, Arizona|
|Phoenix, Arizona, United States, 85006|
|United States, Arkansas|
|Little Rock, Arkansas, United States, 72207|
|United States, California|
|Beverley Hills, California, United States, 90211|
|Fountain Valley, California, United States, 92708|
|Long Beach, California, United States, 60813|
|Los Angeles, California, United States, 90033|
|Newport Beach, California, United States, 92663|
|Oakland, California, United States, 94609|
|San Diego, California, United States, 92103|
|San Francisco, California, United States, 94110|
|Stanford, California, United States, 94305-5107|
|Sunnyvale, California, United States, 94086|
|Torrance, California, United States, 90502|
|United States, Colorado|
|Denver, Colorado, United States, 80220|
|United States, Connecticut|
|Norwalk, Connecticut, United States, 06851|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|Atlantis, Florida, United States, 33462|
|Fort Lauderdale, Florida, United States, 33308|
|Miami, Florida, United States, 33136|
|North Miami Beach, Florida, United States, 33169|
|North Palm Beach, Florida, United States, 33408|
|Orlando, Florida, United States, 32803|
|Sarasota, Florida, United States, 34239|
|Tampa, Florida, United States, 33602|
|Vero Beach, Florida, United States, 32960|
|United States, Georgia|
|Decatur, Georgia, United States, 30033|
|Macon, Georgia, United States, 31201|
|United States, Illinois|
|Chicago, Illinois, United States, 60657|
|United States, Maryland|
|Baltimore, Maryland, United States, 21205|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215-3318|
|Springfield, Massachusetts, United States, 01107|
|United States, Michigan|
|Detroit, Michigan, United States, 48202|
|United States, Missouri|
|St. Louis, Missouri, United States, 63108|
|United States, Nevada|
|Henderson, Nevada, United States, 89074|
|United States, New Jersey|
|Hillsborough, New Jersey, United States, 08844|
|United States, New Mexico|
|Santa Fe, New Mexico, United States, 87505|
|United States, New York|
|Albany, New York, United States, 12208-3479|
|Manhasset, New York, United States, 11030|
|New York City, New York, United States, 10016|
|United States, North Carolina|
|Huntersville, North Carolina, United States, 28078|
|Winston-Salem, North Carolina, United States, 27157-1042|
|United States, Ohio|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|Hershey, Pennsylvania, United States, 17033|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, South Carolina|
|Columbia, South Carolina, United States, 29206|
|United States, Texas|
|Dallas, Texas, United States, 75204|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Annandale, Virginia, United States, 22003-7313|
|Hampton, Virginia, United States, 23666|
|United States, Washington|
|Seattle, Washington, United States, 98101|
|Tacoma, Washington, United States, 98405|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|San Juan, Puerto Rico, 00921-3201|
|Santurce, Puerto Rico, 00909|
Sponsors and CollaboratorsGilead Sciences
Additional Information:Gilead Website
|Responsible Party:||Kitty Yale, Gilead Sciences INC|
|ClinicalTrials.gov Identifier:||NCT00298350 History of Changes|
|Other Study ID Numbers:||GS-US-183-0105|
|Study First Received:||February 28, 2006|
|Last Updated:||July 28, 2008|
Keywords provided by Gilead Sciences:Phase 2
Highly Activity Antiretroviral Therapy
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Protease Inhibitors
ClinicalTrials.gov processed this data on December 14, 2018
This information is provided by ClinicalTrials.gov.