At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Emtricitabinedrug
Likely dose
Emtricitabine 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa With Continued Access to Emtricitabine
In Brief
A Phase 2 clinical trial evaluating Emtricitabine for HIV-1 Infection. Completed, enrolled 50 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesSouth Africa
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedAug 2008
Primary CompletionFeb 2017
TodayJul 2026
First PostedAug 28, 2008
Enrollment StartNov 22, 2005
Primary CompletionFeb 13, 2017
TodayJul 2, 2026
Enrollment to primary: 11.2 yearsPosted 17.8 years ago
Interventions
Emtricitabinedrug
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