A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1

The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.

Study Overview

• Status: Terminated
• Conditions: HIV Infection
• Intervention / Treatment: Drug: FUZEON [enfuvirtide]

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Hobson City, Alabama, United States, 36201
  • California
    • Los Angeles, California, United States, 90036
    • Los Angeles, California, United States, 90033
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20007
    • Washington, D.C., District of Columbia, United States, 20009
  • Florida
    • Orlando, Florida, United States, 32803
  • Georgia
    • Atlanta, Georgia, United States, 30308
    • Macon, Georgia, United States, 31201
  • Illinois
    • Chicago, Illinois, United States, 60612
    • Chicago, Illinois, United States, 60657
  • Maryland
    • Baltimore, Maryland, United States, 21201
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-3318
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4505
  • Missouri
    • Saint Louis, Missouri, United States, 63139
  • New Jersey
    • Newark, New Jersey, United States, 07103
  • New York
    • New York, New York, United States, 10016
    • New York, New York, United States, 10011
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
  • Texas
    • Dallas, Texas, United States, 75246
    • Houston, Texas, United States, 77004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• CD4 cell count greater than 50 cells/mm^3
• HIV-1 RNA viral load greater than or equal to 5000 copies/mL
• Patients must be HIV treatment experienced
• Patients diagnosed with HIV-1 infection

Exclusion Criteria:

• Female patients must not be able to have children or must be under effective contraceptives
• Female patients who are pregnant
• Have taken enfuvirtide and/or T-1249 before
• Have serious kidney problems
• Alcohol and/or drug abuse
• Have had an organ transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2004
• Primary Completion (ACTUAL): July 16, 2005
• Study Completion (ACTUAL): July 16, 2005

Study Registration Dates

• First Submitted: January 7, 2005
• First Submitted That Met QC Criteria: January 7, 2005
• First Posted (ESTIMATE): January 10, 2005

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: December 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Enfuvirtide
• Other Study ID Numbers: ML18021