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

Primary Outcome Measures:

• Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
  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.
  
  

Secondary Outcome Measures:

• Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
  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.
  
  
• Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
  Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
  
  
• Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
  Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.
  
  
• AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800) [ Time Frame: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1) ]
  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.
  
  
• Number of Participants With Adverse Events (AEs) and Serious AEs [ Time Frame: Up to Week 4 after discontinuation of therapy ]
  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.
  
  
• Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities [ Time Frame: Up to Week 96 ]
  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.
  
  
• Number of Participants Who Died [ Time Frame: Up to Week 96 ]
  
• Number of Participants Who Prematurely Withdrew Due to AE [ Time Frame: Up to Week 96 ]
  
• Number of Participants With Worst Local Injection Site Reactions [ Time Frame: Up to Week 96 ]
  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.
  
  

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.