Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
This trial is active, not recruiting.
|Start date||November 2005|
|End date||December 2020|
|Trial size||49 participants|
|Trial identifier||NCT00743340, GS-US-162-0112|
The purpose of this study is to provide current FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine, following completion of the FTC-203 study. Individuals participating in this rollover protocol will receive emtricitabine, for as long as they continue to meet specific virologic criteria and until they withdraw from study, experiences a toxicity that necessitates the permanent discontinuation of emtricitabine, or emtricitabine is approved in the country of residence.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||single group assignment|
There is no primary outcome measure. Only SAEs, AEs leading to discontinuation of the study drug, emtricitabine, regardless of seriousness/severity and AEs associated with skin discoloration (hyperpigmentation) will be collected
time frame: 720 weeks
Male or female participants from 1 month up to 17 years old.
- 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.
|Official title||A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine|
|Description||In addition to access to emtricitabine, the study will collect long-term safety information in participants receiving emtricitabine in combination with other antiretroviral agents. Data collection during the rollover protocol for safety purposes will be limited to the reporting of adverse events (AEs) that (1) meet the criteria for a serious adverse event (SAE), (2) result in permanent discontinuation of the study drug, emtricitabine, and/or (3) are associated with skin discoloration (hyperpigmentation).|
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