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

NCT00743340 | Completed Phase 2 Results FDA Drug

• 1 other identifier: GS-US-162-0112
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV-1 Infection

Keywords

HIV-1 infection; emtricitabine; pediatrics; pediatric patients

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Had Access to, and Received the Intervention

  This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.

  Up to 586 weeks

Study Arms (1)

Emtricitabine

EXPERIMENTAL

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

Interventions

Emtricitabine DRUG

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

Emtricitabine

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (2)

Themba Lethu Clinic, Helen Joseph Hospital, Westdene

Johannesburg, South Africa

Location

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

Soweto, South Africa

Location

MeSH Terms

Interventions

Emtricitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Clinical Trial Disclosures & Data Transparency
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: November 22, 2005
• Primary Completion: February 13, 2017
• Study Completion: February 13, 2017
• Last Updated: April 26, 2018
• Results First Posted: April 26, 2018

Record last verified: 2018-03

Locations

ZA (2)