We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
(Insufficient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00100984
First Posted: January 10, 2005
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
January 7, 2005
January 10, 2005
June 20, 2017
July 21, 2004
July 16, 2005   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00100984 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Primary Purpose: Treatment
HIV Infection
Drug: FUZEON [enfuvirtide]
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
July 16, 2005
July 16, 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00100984
ML18021
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Not Provided
Hoffmann-La Roche
December 2005

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