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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00022763
• Collaborator: Trimeris (Industry)
• Enrollment: 52
• Locations: 7
• Patients Per Site: 7.4

Study Details

Study Description

Brief Summary

This study will evaluate T-20 in children.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Enfuvirtide	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Pharmacokinetic and Safety Study of T-20 in Combination With an Optimized Background in HIV Infected Children and Adolescents
• Study Start Date: Aug 1, 2001
• Actual Primary Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) [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

1. Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) [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.

2. Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide [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.

3. Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) [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.

4. AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800) [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.

5. Number of Participants With Adverse Events (AEs) and Serious AEs [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.

6. Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities [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.

7. Number of Participants Who Died [Up to Week 96]

8. Number of Participants Who Prematurely Withdrew Due to AE [Up to Week 96]

9. Number of Participants With Worst Local Injection Site Reactions [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hosp Los Angeles	Los Angeles	California	United States	90027
2	Univ of Florida Gainesville	Gainesville	Florida	United States	32610
3	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10457
4	Bronx Municipal Hosp Ctr/Jacobi Med Ctr	Bronx	New York	United States	10461
5	New York Hosp - Cornell / Program for Children with AIDS	New York	New York	United States	10021
6	Mount Sinai Hosp	New York	New York	United States	10029
7	Children's Hosp of the King's Daughters	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Hoffmann-La Roche
• Trimeris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00022763
• Other Study ID Numbers: NV16056; T20-310; 295E
• First Posted: Aug 31, 2001
• Last Update Posted: Feb 15, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Hoffmann-La Roche: Anti-HIV Agents; pentafuside
• Additional relevant MeSH terms: HIV Infections; Enfuvirtide

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	24	28
COMPLETED	15	11
NOT COMPLETED	9	17

Baseline Characteristics

Arm/Group Title	Stratum A	Stratum B	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	24	28	52
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.7 (1.8)	13.9 (1.6)	11.5 (3.1)
Sex: Female, Male (Count of Participants)
Female	15 62.5%	9 32.1%	24 46.2%
Male	9 37.5%	19 67.9%	28 53.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	12	13
Enfuvirtide	56.1 (19.4)	52.7 (27.4)
Metabolite (Ro 50-6343)	3.07 (2.77)	3.41 (2.09)

2. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)
Description	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 Frame	Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Outcome Measure Data

Analysis Population Description

Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	12	13
Enfuvirtide	6.43 (2.15)	5.88 (2.81)
Metabolite (Ro 50-6343)	0.434 (0.667)	0.450 (0.341)

3. Secondary Outcome

Title	Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide
Description	Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time Frame	Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Outcome Measure Data

Analysis Population Description

Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	12	13
Mean (Standard Deviation) [hour]	4.13 (1.35)	5.05 (2.67)

4. Secondary Outcome

Title	Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)
Description	Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.
Time Frame	Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Outcome Measure Data

Analysis Population Description

Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	12	13
Enfuvirtide	2.87 (1.49)	2.98 (1.66)
Metabolite (Ro 50-6343)	0.177 (0.089)	0.242 (0.146)

5. Secondary Outcome

Title	AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)
Description	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.
Time Frame	Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Outcome Measure Data

Analysis Population Description

Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	12	13
Mean (Standard Deviation) [Ratio]	5.31 (3.55)	7.12 (3.98)

6. Secondary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious AEs
Description	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.
Time Frame	Up to Week 4 after discontinuation of therapy

Outcome Measure Data

Analysis Population Description

Safety Analysis Population: All participants who received at least one dose of study medication were included.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	24	28
Any AE	24 100%	25 89.3%
Any SAE	8 33.3%	15 53.6%

7. Secondary Outcome

Title	Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities
Description	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.
Time Frame	Up to Week 96

Outcome Measure Data

Analysis Population Description

Safety Analysis Population: All participants who received at least one dose of study medication were included.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	24	26
Platelets Grade 3	0 0%	2 7.1%
Platelets Grade 4	1 4.2%	0 0%
Neutrophils Grade 3	0 0%	0 0%
Neutrophils Grade 4	1 4.2%	0 0%
ASAT Grade 3	2 8.3%	0 0%
ASAT Grade 4	0 0%	0 0%
ALAT Grade 3	1 4.2%	0 0%
ALAT Grade 4	0 0%	0 0%
Total Bilirubin Grade 3	0 0%	1 3.6%
Total Bilirubin Grade 4	0 0%	0 0%
GGT Grade 3	0 0%	1 3.6%
GGT Grade 4	0 0%	0 0%
Amylase Grade 3	1 4.2%	1 3.6%
Amylase Grade 4	1 4.2%	1 3.6%

8. Secondary Outcome

Title	Number of Participants Who Died
Time Frame	Up to Week 96

Outcome Measure Data

Analysis Population Description

Safety Analysis Population: All participants who received at least one dose of study medication were included.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	24	28
Number [participants]	1 4.2%	1 3.6%

9. Secondary Outcome

Title	Number of Participants Who Prematurely Withdrew Due to AE
Time Frame	Up to Week 96

Outcome Measure Data

Analysis Population Description

Safety Analysis Population: All participants who received at least one dose of study medication were included.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	24	28
Number [participants]	9 37.5%	17 60.7%

10. Secondary Outcome

Title	Number of Participants With Worst Local Injection Site Reactions
Description	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.
Time Frame	Up to Week 96

Outcome Measure Data

Analysis Population Description

Safety Analysis Population: All participants who received at least one dose of study medication were included.

Arm/Group Title	Stratum A	Stratum B
Arm/Group Description	Participants of age >= 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.	Participants of age >= 12 years and less than 17 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.
Measure Participants	24	28
Erythema	13 54.2%	19 67.9%
Nodules and Cysts	16 66.7%	14 50%
Induration	21 87.5%	20 71.4%
Pruritus	10 41.7%	9 32.1%
Ecchymosis	6 25%	8 28.6%
Others	5 20.8%	10 35.7%

Adverse Events

Time Frame	Up to Week 96
Adverse Event Reporting Description	All participants who received at least one dose of study medication were included in safety analysis.
Arm/Group Title	Enfuvirtide
Arm/Group Description	Participants in stratum A (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) and in stratum B (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).
All Cause Mortality
	Enfuvirtide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Enfuvirtide
	Affected / at Risk (%)	# Events
Total	31/52 (59.6%)
Blood and lymphatic system disorders
Neutropenia	1/52 (1.9%)
General disorders
Pyrexia	2/52 (3.8%)
Injection site abscess	1/52 (1.9%)
Multi-organ failure	1/52 (1.9%)
Infections and infestations
Pneumonia nos	4/52 (7.7%)
Cellulitis	3/52 (5.8%)
Gastroenteritis nos	2/52 (3.8%)
Bronchiolitis	1/52 (1.9%)
Bronchitis nos	1/52 (1.9%)
Colitis pseudomembranous	1/52 (1.9%)
Gastroenteritis viral nos	1/52 (1.9%)
Kawasaki's disease	1/52 (1.9%)
Lobar pneumonia nos	1/52 (1.9%)
Pneumonia viral nos	1/52 (1.9%)
Septic shock	1/52 (1.9%)
Sinusitis nos	1/52 (1.9%)
Staphylococcal abscess	1/52 (1.9%)
Investigations
Blood creatinine increased	1/52 (1.9%)
Blood urea increased	1/52 (1.9%)
Metabolism and nutrition disorders
Metabolic disorder nos	1/52 (1.9%)
Tetany	1/52 (1.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat gland tumour	1/52 (1.9%)
Nervous system disorders
Dystonia	1/52 (1.9%)
Skin and subcutaneous tissue disorders
Rash papular	1/52 (1.9%)
Other (Not Including Serious) Adverse Events
	Enfuvirtide
	Affected / at Risk (%)	# Events
Total	52/52 (100%)
Blood and lymphatic system disorders
Lymphadenopathy	7/52 (13.5%)
Ear and labyrinth disorders
Earache	3/52 (5.8%)
Eye disorders
Conjunctivitis nec	5/52 (9.6%)
Conjunctivitis allergic	4/52 (7.7%)
Vision blurred	3/52 (5.8%)
Gastrointestinal disorders
Nausea	11/52 (21.2%)
Vomiting nos	11/52 (21.2%)
Diarrhoea nos	9/52 (17.3%)
Abdominal pain nos	7/52 (13.5%)
Abdominal pain upper	6/52 (11.5%)
Loose stools	5/52 (9.6%)
Sore throat nos	4/52 (7.7%)
Mouth ulceration	3/52 (5.8%)
General disorders
Pyrexia	11/52 (21.2%)
Fatigue	6/52 (11.5%)
Immune system disorders
Hypersensitivity Nos	4/52 (7.7%)
Infections and infestations
Upper respiratory tract infection nos	22/52 (42.3%)
Otitis media nos	12/52 (23.1%)
Nasopharyngitis	9/52 (17.3%)
Sinusitis nos	8/52 (15.4%)
Oral candidiasis	6/52 (11.5%)
Body tinea	4/52 (7.7%)
Impetigo nos	4/52 (7.7%)
Viral infection nos	4/52 (7.7%)
Gastroenteritis nos	3/52 (5.8%)
Herpes simplex	3/52 (5.8%)
Herpes zoster	4/52 (7.7%)
Injury, poisoning and procedural complications
Arthropod bite	3/52 (5.8%)
Investigations
Weight decreased	5/52 (9.6%)
Haematuria present	3/52 (5.8%)
Metabolism and nutrition disorders
Appetite decreased nos	3/52 (5.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	3/52 (5.8%)
Back Pain	3/52 (5.8%)
Nervous system disorders
Headache Nos	6/52 (11.5%)
Renal and urinary disorders
Dysuria	3/52 (5.8%)
Respiratory, thoracic and mediastinal disorders
Cough	13/52 (25%)
Bronchospasm nos	6/52 (11.5%)
Nasal congestion	6/52 (11.5%)
Rhinitis allergic nos	4/52 (7.7%)
Rhinorrhoea	4/52 (7.7%)
Asthma nos	3/52 (5.8%)
Wheezing	3/52 (5.8%)
Skin and subcutaneous tissue disorders
Dermatitis Nos	10/52 (19.2%)
Acne Nos	5/52 (9.6%)
Eczema Seborrhoeic	3/52 (5.8%)
Rash papular	3/52 (5.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.