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

February 28, 2006
July 28, 2008
February 2006
June 2007   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00298350 on ClinicalTrials.gov Archive Site
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Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HIV
  • HIV-1
  • Human Immunodeficiency Virus
Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
July 2007
June 2007   (final data collection date for primary outcome measure)

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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00298350
GS-US-183-0105
Yes
Kitty Yale, Gilead Sciences INC
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP