Status:
COMPLETED
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
Lead Sponsor:
Gilead Sciences
Conditions:
HIV-1 Infection
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 22 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00743340
Start Date
November 22 2005
End Date
February 13 2017
Last Update
April 26 2018
Active Locations (2)
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1
Themba Lethu Clinic, Helen Joseph Hospital, Westdene
Johannesburg, South Africa
2
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Soweto, South Africa