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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
United States, Arkansas
Little Rock, Arkansas, United States, 72207
United States, California
Beverley Hills, California, United States, 90211
Fountain Valley, California, United States, 92708
Long Beach, California, United States, 60813
Los Angeles, California, United States, 90033
Newport Beach, California, United States, 92663
Oakland, California, United States, 94609
San Diego, California, United States, 92103
San Francisco, California, United States, 94110
Stanford, California, United States, 94305-5107
Sunnyvale, California, United States, 94086
Torrance, California, United States, 90502
United States, Colorado
Denver, Colorado, United States, 80220
United States, Connecticut
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Florida
Atlantis, Florida, United States, 33462
Fort Lauderdale, Florida, United States, 33308
Miami, Florida, United States, 33136
North Miami Beach, Florida, United States, 33169
North Palm Beach, Florida, United States, 33408
Orlando, Florida, United States, 32803
Sarasota, Florida, United States, 34239
Tampa, Florida, United States, 33602
Vero Beach, Florida, United States, 32960
United States, Georgia
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
United States, Illinois
Chicago, Illinois, United States, 60657
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Boston, Massachusetts, United States, 02215-3318
Springfield, Massachusetts, United States, 01107
United States, Michigan
Detroit, Michigan, United States, 48202
United States, Missouri
St. Louis, Missouri, United States, 63108
United States, Nevada
Henderson, Nevada, United States, 89074
United States, New Jersey
Hillsborough, New Jersey, United States, 08844
United States, New Mexico
Santa Fe, New Mexico, United States, 87505
United States, New York
Albany, New York, United States, 12208-3479
Manhasset, New York, United States, 11030
New York City, New York, United States, 10016
United States, North Carolina
Huntersville, North Carolina, United States, 28078
Winston-Salem, North Carolina, United States, 27157-1042
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Columbia, South Carolina, United States, 29206
United States, Texas
Dallas, Texas, United States, 75204
Houston, Texas, United States, 77030
United States, Virginia
Annandale, Virginia, United States, 22003-7313
Hampton, Virginia, United States, 23666
United States, Washington
Seattle, Washington, United States, 98101
Tacoma, Washington, United States, 98405
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Puerto Rico
San Juan, Puerto Rico, 00921-3201
Santurce, Puerto Rico, 00909
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 August 28, 2014