Phase 2
Completed N=52
T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents
Source: ClinicalTrials.gov NCT00022763 ↗Enrolled (actual)
52
Serious AEs
59.6%
Results posted
Feb 2016
Primary outcomePrimary: Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) — 56.1; 52.7; 3.07; 3.41 microgram hour per milliliter (mcg.h/mL)
Summary
This study will evaluate T-20 in children.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) |
56.1; 52.7; 3.07; 3.41 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) |
6.43; 5.88; 0.434; 0.450 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide |
4.13; 5.05 | — |
| SECONDARY Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) |
2.87; 2.98; 0.177; 0.242 | — |
| SECONDARY AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800) |
5.31; 7.12 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious AEs |
24; 25; 8; 15 | — |
| SECONDARY Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities |
0; 2; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Died |
1; 1 | — |
| SECONDARY Number of Participants Who Prematurely Withdrew Due to AE |
9; 17 | — |
| SECONDARY Number of Participants With Worst Local Injection Site Reactions |
13; 19; 16; 14; 21; 20 | — |
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are 3 through 16 years of age and have the consent of parent or guardian.
- Have a viral load of at least 5000 copies/ml.
- Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
- Have been on stable therapy for at least 4 weeks.
Data sourced from ClinicalTrials.gov (NCT00022763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.