Back to resultsRitonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
Primary Purpose
HIV, HIV-1, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GS-9137 - A Novel HIV-1 Integrase Inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring Phase 2, Phase II, Randomized, Controlled, Comparator, Partially Blind, Protease Inhibitors, Integrase Inhibitors, Antiviral Agents, Antiretroviral Agents, ART, ARV, Highly Activity Antiretroviral Therapy, HAART, Treatment Experienced
Eligibility Criteria
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).
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00298350
Brief Title
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV-1, Human Immunodeficiency Virus
Keywords
Phase 2, Phase II, Randomized, Controlled, Comparator, Partially Blind, Protease Inhibitors, Integrase Inhibitors, Antiviral Agents, Antiretroviral Agents, ART, ARV, Highly Activity Antiretroviral Therapy, HAART, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GS-9137 - A Novel HIV-1 Integrase Inhibitor
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
City
Beverley Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
60813
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5107
Country
United States
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-3318
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3479
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
New York City
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1042
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003-7313
Country
United States
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
20146631
Citation
Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, Kearney BP, Cheng AK. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis. 2010 Mar 15;201(6):814-22. doi: 10.1086/650698.
Results Reference
derived
Links:
URL
http://www.Gilead.com
Description
Gilead Website
Learn more about this trial
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
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