This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00100984
First received: January 7, 2005
Last updated: June 19, 2017
Last verified: December 2005
January 7, 2005
June 19, 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