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
  Purpose

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 Intervention Phase
HIV
HIV-1
Human Immunodeficiency Virus
Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Enrollment: 278
Study Start Date: February 2006
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing 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

  Show 54 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

Additional Information:
No publications provided by Gilead Sciences

Additional 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
Study First Received: February 28, 2006
Last Updated: July 28, 2008
Health Authority: United States: Food and Drug Administration

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Protease Inhibitors
Ritonavir
HIV Protease Inhibitors
Anti-Retroviral Agents
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 08, 2014