- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00048217
A Rollover Study to Provide Chronic T-1249 to Patients Who Completed Study T1249-102
June 23, 2005 updated by: Trimeris
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
-
Durham, North Carolina, United States, 27707
- Trimeris
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Completion T1249-102;
- Currently failing a T-20 containing regimen
Exclusion Criteria:
- Non-completion of T1249-102.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 28, 2002
First Submitted That Met QC Criteria
October 29, 2002
First Posted (Estimate)
October 30, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
July 1, 2004
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T1249-105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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