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

HIV-1 Infection Clinical Trial

Official title:

A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743340
• Other study ID #: GS-US-162-0112
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2008
• Last updated: March 28, 2018
• Start date: November 22, 2005
• Est. completion date: February 13, 2017

Study information

• Verified date: March 2018
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 13, 2017
• Est. primary completion date: February 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

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

Locations

Country	Name	City	State
South Africa	Themba Lethu Clinic, Helen Joseph Hospital, Westdene	Johannesburg
South Africa	Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital	Soweto

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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