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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

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ClinicalTrials.gov Identifier: NCT00100984
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : January 10, 2005
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: FUZEON [enfuvirtide] Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Primary Purpose: Treatment
Actual Study Start Date : July 21, 2004
Actual Primary Completion Date : July 16, 2005
Actual Study Completion Date : July 16, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT00100984


Locations
United States, Alabama
Hobson City, Alabama, United States, 36201
United States, California
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90036
United States, District of Columbia
Washington, D.C., District of Columbia, United States, 20007
Washington, D.C., District of Columbia, United States, 20009
United States, Florida
Orlando, Florida, United States, 32803
United States, Georgia
Atlanta, Georgia, United States, 30308
Macon, Georgia, United States, 31201
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60657
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02215-3318
United States, Mississippi
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Saint Louis, Missouri, United States, 63139
United States, New Jersey
Newark, New Jersey, United States, 07103
United States, New York
New York, New York, United States, 10011
New York, New York, United States, 10016
United States, North Carolina
Huntersville, North Carolina, United States, 28078
United States, Texas
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77004
Sponsors and Collaborators
Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00100984     History of Changes
Other Study ID Numbers: ML18021
First Posted: January 10, 2005    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: December 2005

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lopinavir
Saquinavir
Enfuvirtide
 HIV Protease Inhibitors
Protease 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
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors