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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Gilead Sciences Identifier:
First received: August 26, 2008
Last updated: January 25, 2016
Last verified: January 2016
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.

Condition Intervention Phase
HIV-1 Infection
Drug: Emtricitabine
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: November 2005
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Emtricitabine
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.

Detailed 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).

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00743340

South Africa
Themba Lethu Clinic, Helen Joseph Hospital, Westdene
Johannesburg, South Africa
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Soweto, South Africa
Sponsors and Collaborators
Gilead Sciences
Study Director: Erin Quirk, MD Gilead Sciences
  More Information

Responsible Party: Gilead Sciences Identifier: NCT00743340     History of Changes
Other Study ID Numbers: GS-US-162-0112 
Study First Received: August 26, 2008
Last Updated: January 25, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV-1 infection
pediatric patients

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors processed this record on May 30, 2016