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

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ClinicalTrials.gov Identifier: NCT00298350
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : July 29, 2008
Sponsor:
Information provided by:
Gilead Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV HIV-1 Human Immunodeficiency Virus Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
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.
Study Start Date : February 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298350


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Sponsors and Collaborators
Gilead Sciences
More Information
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Additional Information:
Gilead Website  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kitty Yale, Gilead Sciences INC
ClinicalTrials.gov Identifier: NCT00298350     History of Changes
Other Study ID Numbers: GS-US-183-0105
First Posted: March 2, 2006    Key Record Dates
Last Update Posted: July 29, 2008
Last Verified: July 2008

Keywords provided by Gilead Sciences:
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

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
 HIV Protease Inhibitors
Protease Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors