Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.

This study has been completed.

Sponsor:

Information provided by:

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT00298350

First received: February 28, 2006

Last updated: July 28, 2008

Last verified: July 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	February 28, 2006
Last Updated Date	July 28, 2008
Start Date ^ICMJE	February 2006
Primary Completion Date	June 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00298350 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
Official Title ^ICMJE	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.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	HIV HIV-1 Human Immunodeficiency Virus
Intervention ^ICMJE	Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor
Study Arm (s)	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	278
Completion Date	July 2007
Primary Completion Date	June 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Puerto Rico

Administrative Information
NCT Number ^ICMJE	NCT00298350
Other Study ID Numbers ^ICMJE	GS-US-183-0105
Has Data Monitoring Committee	Yes
Responsible Party	Kitty Yale, Gilead Sciences INC
Study Sponsor ^ICMJE	Gilead Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Gilead Sciences
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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