Overview

This trial is active, not recruiting.

Condition hiv-1 infection
Treatment emtricitabine
Phase phase 2
Sponsor Gilead Sciences
Start date November 2005
End date December 2020
Trial size 49 participants
Trial identifier NCT00743340, GS-US-162-0112

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(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.
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.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 1 month up to 17 years old.

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. Exclusion Criteria:

Additional Information

Official title A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine
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).
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Gilead Sciences.