Back to resultsA Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
T-1249
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced
Eligibility Criteria
Inclusion Criteria: Completion T1249-102; Currently failing a T-20 containing regimen Exclusion Criteria: Non-completion of T1249-102.
Sites / Locations
- Trimeris
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00048217
Brief Title
A Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102
Study Type
Interventional
2. Study Status
Record Verification Date
July 2004
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Trimeris
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
T-1249
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion T1249-102;
Currently failing a T-20 containing regimen
Exclusion Criteria:
Non-completion of T1249-102.
Facility Information:
Facility Name
Trimeris
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102
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