Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
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.
Emtricitabine (FTC) administered based on body weight at a dose of 6 mg/kg once daily, with a maximum dose of 200 mg once daily with the capsule formulation (for children weighing ≥ 33 kg) or a maximum dose of up to 240 mg once daily with the oral solution formulation.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743340
|Themba Lethu Clinic, Helen Joseph Hospital, Westdene|
|Johannesburg, South Africa|
|Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital|
|Soweto, South Africa|
|Study Director:||Sean Bennett, MD, PhD||Gilead Sciences|