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A Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102

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.
 
ClinicalTrials.gov Identifier: NCT00048217
Recruitment Status : Unknown
Verified July 2004 by Trimeris.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Trimeris

Tracking Information
First Submitted Date  ICMJE October 28, 2002
First Posted Date  ICMJE October 30, 2002
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102
Official Title  ICMJE Not Provided
Brief Summary Patients who complete study T1249-102 (must be currently failing a T-20 containing regimen to participate in this study) will receive T-1249 at a dose of 200mg daily in combination with a background antiretroviral regimen for 96 weeks. Only patients that participated in study T1249-102 can participate in study T1249-105.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Drug: T-1249
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completion T1249-102;
  • Currently failing a T-20 containing regimen

Exclusion Criteria:

  • Non-completion of T1249-102.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00048217
Other Study ID Numbers  ICMJE T1249-105
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Trimeris
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Trimeris
Verification Date July 2004

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