At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 52 enrolled
Drug / intervention
Enfuvirtidedrug
Likely dose
Not stated in record
Key inclusion· 4
- ✓Age 3 through 16 years
- ✓Viral load at least 5000 copies/ml
- ✓Prior exposure to at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months
- ✓On stable therapy for at least 4 weeks
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents
In Brief
A Phase 2 clinical trial evaluating Enfuvirtide for HIV Infections. Completed, enrolled 52 participants across 7 sites.
Detailed Summary
This study will evaluate T-20 in children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
CollaboratorsTrimeris
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2001
First PostedAug 2001
Primary CompletionDec 2004
TodayJul 2026
First PostedAug 31, 2001
Enrollment StartAug 1, 2001
Primary CompletionDec 1, 2004
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 24.8 years ago
Interventions
Enfuvirtidedrug