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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	HIV Infections
Intervention:	Drug: Enfuvirtide

  Participant Flow

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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

  Baseline Characteristics

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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

  Outcome Measures

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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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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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Results Point of Contact:  

Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00022763 History of Changes
Other Study ID Numbers:	NV16056; T20-310; 295E
First Submitted:	August 11, 2001
First Posted:	August 31, 2001
Results First Submitted:	December 4, 2015
Results First Posted:	February 15, 2016
Last Update Posted:	February 15, 2016