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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall, 52 participants were enrolled in this study conducted at 16 centers in Spain and United States between 23 August 2001 and 09 December 2004.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Stratum A	Participants of age greater than or equal to (>=) 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Stratum B	Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.

Participant Flow:   Overall Study

	Stratum A	Stratum B
STARTED	24	28
COMPLETED	15	11
NOT COMPLETED	9	17
Adverse Event	1	2
Injection Site Reactions	0	2
Death	0	1
Lost to Follow-up	0	3
Withdrawal by Subject	4	7
Insufficient Therapy	1	0
Admin	3	2

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Stratum A	Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Stratum B	Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
Total	Total of all reporting groups

Baseline Measures

	Stratum A	Stratum B	Total
Overall Participants Analyzed  [Units: Participants]	24	28	52
Age  [Units: Years] Mean (Standard Deviation)	8.7  (1.8)	13.9  (1.6)	11.5  (3.1)
Gender  [Units: Participants]
Female	15	9	24
Male	9	19	28

1.  Primary:

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) ]

2.  Secondary:

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) ]

3.  Secondary:

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) ]

4.  Secondary:

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) ]

5.  Secondary:

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) ]

6.  Secondary:

Number of Participants With Adverse Events (AEs) and Serious AEs   [ Time Frame: Up to Week 4 after discontinuation of therapy ]

7.  Secondary:

Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities   [ Time Frame: Up to Week 96 ]

8.  Secondary:

Number of Participants Who Died   [ Time Frame: Up to Week 96 ]

9.  Secondary:

Number of Participants Who Prematurely Withdrew Due to AE   [ Time Frame: Up to Week 96 ]

10.  Secondary:

Number of Participants With Worst Local Injection Site Reactions   [ Time Frame: Up to Week 96 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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