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

July 28, 2008 updated by: Gilead Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00921-3201
      • Santurce, Puerto Rico, 00909
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • Arkansas
      • Little Rock, Arkansas, United States, 72207
    • 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
    • Colorado
      • Denver, Colorado, United States, 80220
    • Connecticut
      • Norwalk, Connecticut, United States, 06851
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • 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
    • Georgia
      • Decatur, Georgia, United States, 30033
      • Macon, Georgia, United States, 31201
    • Illinois
      • Chicago, Illinois, United States, 60657
    • Maryland
      • Baltimore, Maryland, United States, 21205
    • Massachusetts
      • Boston, Massachusetts, United States, 02215-3318
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Missouri
      • St. Louis, Missouri, United States, 63108
    • Nevada
      • Henderson, Nevada, United States, 89074
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
    • New York
      • Albany, New York, United States, 12208-3479
      • Manhasset, New York, United States, 11030
      • New York City, New York, United States, 10016
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
      • Winston-Salem, North Carolina, United States, 27157-1042
    • Ohio
      • Cleveland, Ohio, United States, 44106
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Philadelphia, Pennsylvania, United States, 19107
    • South Carolina
      • Columbia, South Carolina, United States, 29206
    • Texas
      • Dallas, Texas, United States, 75204
      • Houston, Texas, United States, 77030
    • Virginia
      • Annandale, Virginia, United States, 22003-7313
      • Hampton, Virginia, United States, 23666
    • Washington
      • Seattle, Washington, United States, 98101
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (Estimate)

March 2, 2006

Study Record Updates

Last Update Posted (Estimate)

July 29, 2008

Last Update Submitted That Met QC Criteria

July 28, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-183-0105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe