HIV-1 Infection
Conditions
Keywords
HIV-1 infection, emtricitabine, pediatrics, pediatric patients
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.
Interventions
DRUGEmtricitabine
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
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had Access to, and Received the Intervention | Up to 586 weeks | This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. |
Countries
South Africa
Participant flow
Recruitment details
Participants were enrolled at 2 study sites in South Africa. The first participant was screened on 22 November 2005. The last study visit occurred on 13 February 2017.
Pre-assignment details
59 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Emtricitabine Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Participant Relocated | 1 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Rolled over to other Gilead Study | 23 |
| Overall Study | Study medication non-compliance | 1 |
| Overall Study | Virologic failure | 8 |
| Overall Study | Withdrawal from the Study | 5 |
Baseline characteristics
| Characteristic | Emtricitabine |
|---|---|
| Age, Continuous | 8 years STANDARD_DEVIATION 2.5 |
| Race/Ethnicity, Customized Black | 49 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 13 / 50 |
Outcome results
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.
Time frame: Up to 586 weeks
Population: Participants who were enrolled into the study and received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Emtricitabine | Number of Participants Who Had Access to, and Received the Intervention | 50 Participants |