Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743340
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Information provided by (Responsible Party):
Gilead Sciences

August 26, 2008
August 28, 2008
February 12, 2018
April 26, 2018
April 26, 2018
November 22, 2005
February 13, 2017   (Final data collection date for primary outcome measure)
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 However, there were no prespecified endpoints in this study.
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 ]
Complete list of historical versions of study NCT00743340 on Archive Site
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Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
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.
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Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
HIV-1 Infection
Drug: Emtricitabine
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
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.
Intervention: Drug: Emtricitabine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 13, 2017
February 13, 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
1 Month to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
South Africa
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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Gilead Sciences
Gilead Sciences
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Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP