- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00743340
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
March 28, 2018 updated by: Gilead Sciences
A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine
The primary objectives of this trial are to provide FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine (FTC), following completion of the FTC-203 study and to collect long-term safety information in participants receiving emtricitabine in combination with other antiretroviral agents.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
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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-
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Johannesburg, South Africa
- Themba Lethu Clinic, Helen Joseph Hospital, Westdene
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Soweto, South Africa
- Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
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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
1 month to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- Complete or have previously completed at least through the Week 96 Visit (i.e., 96 weeks on study) for the FTC-203 study.
- Complete all End-of-Study Visit procedures for the FTC-203 study.
- Either (a) have a plasma HIV-1 RNA viral load of ≤ 400 copies/mL at the End-of-Study Visit for the FTC-203 study, or (b) if the subject's plasma HIV-1 RNA viral load at the End-of-Study Visit for FTC-203 study is > 400 copies/mL, their viral load is < 1.0 log10 above the nadir recorded after Week 8 of the FTC-203 study and there is reliable genotypic evidence showing a lack of resistance to emtricitabine.
- A parent or other legal guardian has provided written informed consent to the subject participating in the rollover protocol. As applicable, based on the subject's age and normal institution practice, the subject should additionally provide their written informed consent or assent to participate in the rollover protocol.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Emtricitabine
Participants will receive emtricitabine for as long as they continue to meet specific virologic criteria and until either: (1) the participant chooses to discontinue treatment of emtricitabine and withdraw from the rollover protocol; (2) the participant experiences a toxicity that necessitates the permanent discontinuation of emtricitabine, or (3) emtricitabine is approved for market distribution in the participant's country of residence.
|
6 mg/kg capsule once daily, up to a maximum dose of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Had Access to, and Received the Intervention
Time Frame: Up to 586 weeks
|
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov.
However, there were no prespecified endpoints in this study.
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Up to 586 weeks
|
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 Major Dates
Study Start (ACTUAL)
November 22, 2005
Primary Completion (ACTUAL)
February 13, 2017
Study Completion (ACTUAL)
February 13, 2017
Study Registration Dates
First Submitted
August 26, 2008
First Submitted That Met QC Criteria
August 27, 2008
First Posted (ESTIMATE)
August 28, 2008
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2018
Last Update Submitted That Met QC Criteria
March 28, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-162-0112
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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