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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

This study has been terminated.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00100984
First received: January 7, 2005
Last updated: December 15, 2005
Last verified: December 2005

January 7, 2005
December 15, 2005
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Complete list of historical versions of study NCT00100984 on ClinicalTrials.gov Archive Site
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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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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.

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Interventional
Phase 4
Primary Purpose: Treatment
HIV Infection
Drug: FUZEON [enfuvirtide]
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100984
ML18021
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Hoffmann-La Roche
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Hoffmann-La Roche
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP