This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00743340
First received: August 26, 2008
Last updated: February 21, 2017
Last verified: February 2017
  Purpose
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: 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

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 ]

Enrollment: 50
Actual Study Start Date: November 22, 2005
Study Completion Date: February 13, 2017
Primary Completion Date: February 13, 2017 (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).
  Eligibility

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

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.

  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 ClinicalTrials.gov identifier: NCT00743340

Locations
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
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00743340     History of Changes
Other Study ID Numbers: GS-US-162-0112
Study First Received: August 26, 2008
Last Updated: February 21, 2017

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
emtricitabine
pediatrics
pediatric patients

Additional relevant MeSH terms:
Emtricitabine
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

ClinicalTrials.gov processed this record on August 18, 2017