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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Emtricitabine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine
Actual Study Start Date : November 22, 2005
Actual Primary Completion Date : February 13, 2017
Actual Study Completion Date : February 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Statistical Analysis Plan  [PDF] June 14, 2017
Study Protocol: Amendment  [PDF] July 24, 2013
Study Protocol: Original  [PDF] January 24, 2005

Responsible Party: Gilead Sciences Identifier: NCT00743340     History of Changes
Other Study ID Numbers: GS-US-162-0112
First Posted: August 28, 2008    Key Record Dates
Results First Posted: April 26, 2018
Last Update Posted: April 26, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents