T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents

Study Overview
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Brief Summary
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This study will evaluate T-20 in children.

Detailed Description
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Children are stratified by age group (3 through 11 years and 12 through 16 years). Samples for HIV-1 genotype and phenotype resistance testing are obtained at screening to aid in the selection of concomitant antiretrovirals. Simultaneous to initiating T-20, all patients begin a new optimized antiretroviral regimen based on the patients' prior treatment history, historical resistance testing results, and the results of the testing performed at screening. Patients are followed for safety and other assessments at Weeks 1, 2, and 4, then monthly through Week 24 and bimonthly through Week 48. Pharmacokinetic sampling at selected study visits are performed.

Official Title
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A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Enfuvirtide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enfuvirtide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) | The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) | 
| Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide | Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) | 
| Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) | Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) | 
| AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800) | The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated. | Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) | 
| Number of Participants With Adverse Events (AEs) and Serious AEs | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event. | Up to Week 4 after discontinuation of therapy | 
| Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities | Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively. | Up to Week 96 | 
| Number of Participants Who Died |  | Up to Week 96 | 
| Number of Participants Who Prematurely Withdrew Due to AE |  | Up to Week 96 | 
| Number of Participants With Worst Local Injection Site Reactions | Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded. | Up to Week 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-HIV Agents, pentafuside