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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00743340
First received: August 26, 2008
Last updated: September 24, 2013
Last verified: September 2013

August 26, 2008
September 24, 2013
December 2005
December 2020   (final data collection date for primary outcome measure)
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: Yes ]
Same as current
Complete list of historical versions of study NCT00743340 on ClinicalTrials.gov 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 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. Subjects 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 or emtricitabine is approved in the country of residence.

In addition to access to emtricitabine, the study will collect long-term safety information in subjects 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).

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
HIV-1 Infection
Drug: FTC

FTC capsule 200mg qd

FTC Oral Solution 6mg/kg qd

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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
49
December 2020
December 2020   (final data collection date for primary outcome measure)

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.

Exclusion Criteria:

Both
1 Month to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00743340
GS-US-162-0112
No
Elsa Mondou, MD, Gilead Sciences, Inc.
Gilead Sciences
Not Provided
Not Provided
Gilead Sciences
September 2013

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