Trial Outcomes & Findings for T-20 Plus a Selected Anti-HIV Treatment in HIV-Infected Children and Adolescents (NCT NCT00022763)

NCT ID: NCT00022763

Last Updated: 2016-02-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)
• Results posted on: 2016-02-15

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	24	28
Overall Study COMPLETED	15	11
Overall Study NOT COMPLETED	9	17

Reasons for withdrawal

Measure	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.
Overall Study Adverse Event	1	2
Overall Study Injection Site Reactions	0	2
Overall Study Death	0	1
Overall Study Lost to Follow-up	0	3
Overall Study Withdrawal by Subject	4	7
Overall Study Insufficient Therapy	1	0
Overall Study Admin	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Stratum A n=24 Participants 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 n=28 Participants 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 n=52 Participants Total of all reporting groups
Age, Continuous	8.7 years STANDARD_DEVIATION 1.8 • n=5 Participants	13.9 years STANDARD_DEVIATION 1.6 • n=7 Participants	11.5 years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	19 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Population: 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.

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.

Outcome measures

Measure	Stratum A n=12 Participants 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.	Stratum B n=13 Participants 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.
Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) Metabolite (Ro 50-6343)	3.07 microgram hour per milliliter (mcg.h/mL) Standard Deviation 2.77	3.41 microgram hour per milliliter (mcg.h/mL) Standard Deviation 2.09
Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343) Enfuvirtide	56.1 microgram hour per milliliter (mcg.h/mL) Standard Deviation 19.4	52.7 microgram hour per milliliter (mcg.h/mL) Standard Deviation 27.4

SECONDARY outcome

Timeframe: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Population: 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.

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.

Outcome measures

Measure	Stratum A n=12 Participants 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.	Stratum B n=13 Participants 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.
Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) Enfuvirtide	6.43 mcg/mL Standard Deviation 2.15	5.88 mcg/mL Standard Deviation 2.81
Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343) Metabolite (Ro 50-6343)	0.434 mcg/mL Standard Deviation 0.667	0.450 mcg/mL Standard Deviation 0.341

SECONDARY outcome

Timeframe: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Population: 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.

Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

Outcome measures

Measure	Stratum A n=12 Participants 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.	Stratum B n=13 Participants 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.
Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide	4.13 hour Standard Deviation 1.35	5.05 hour Standard Deviation 2.67

SECONDARY outcome

Timeframe: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Population: 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.

Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.

Outcome measures

Measure	Stratum A n=12 Participants 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.	Stratum B n=13 Participants 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.
Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) Enfuvirtide	2.87 mcg/mL Standard Deviation 1.49	2.98 mcg/mL Standard Deviation 1.66
Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343) Metabolite (Ro 50-6343)	0.177 mcg/mL Standard Deviation 0.089	0.242 mcg/mL Standard Deviation 0.146

SECONDARY outcome

Timeframe: Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)

Population: 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.

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.

Outcome measures

Measure	Stratum A n=12 Participants 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.	Stratum B n=13 Participants 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.
AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)	5.31 Ratio Standard Deviation 3.55	7.12 Ratio Standard Deviation 3.98

SECONDARY outcome

Timeframe: Up to Week 4 after discontinuation of therapy

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

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.

Outcome measures

Measure	Stratum A n=24 Participants 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.	Stratum B n=28 Participants 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.
Number of Participants With Adverse Events (AEs) and Serious AEs Any AE	24 participants	25 participants
Number of Participants With Adverse Events (AEs) and Serious AEs Any SAE	8 participants	15 participants

SECONDARY outcome

Timeframe: Up to Week 96

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

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.

Outcome measures

Measure	Stratum A n=24 Participants 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.	Stratum B n=26 Participants 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.
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities Platelets Grade 3	0 participants	2 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities Platelets Grade 4	1 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities Neutrophils Grade 3	0 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities Neutrophils Grade 4	1 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities ASAT Grade 3	2 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities ASAT Grade 4	0 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities ALAT Grade 3	1 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities ALAT Grade 4	0 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities Total Bilirubin Grade 3	0 participants	1 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities Total Bilirubin Grade 4	0 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities GGT Grade 3	0 participants	1 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities GGT Grade 4	0 participants	0 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities Amylase Grade 3	1 participants	1 participants
Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities Amylase Grade 4	1 participants	1 participants

SECONDARY outcome

Timeframe: Up to Week 96

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

Outcome measures

Measure	Stratum A n=24 Participants 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.	Stratum B n=28 Participants 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.
Number of Participants Who Died	1 participants	1 participants

SECONDARY outcome

Timeframe: Up to Week 96

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

Outcome measures

Measure	Stratum A n=24 Participants 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.	Stratum B n=28 Participants 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.
Number of Participants Who Prematurely Withdrew Due to AE	9 participants	17 participants

SECONDARY outcome

Timeframe: Up to Week 96

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

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.

Outcome measures

Measure	Stratum A n=24 Participants 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.	Stratum B n=28 Participants 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.
Number of Participants With Worst Local Injection Site Reactions Others	5 participants	10 participants
Number of Participants With Worst Local Injection Site Reactions Erythema	13 participants	19 participants
Number of Participants With Worst Local Injection Site Reactions Nodules and Cysts	16 participants	14 participants
Number of Participants With Worst Local Injection Site Reactions Induration	21 participants	20 participants
Number of Participants With Worst Local Injection Site Reactions Pruritus	10 participants	9 participants
Number of Participants With Worst Local Injection Site Reactions Ecchymosis	6 participants	8 participants

Adverse Events

Enfuvirtide

Serious events: 31 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Enfuvirtide n=52 participants at risk 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).
Infections and infestations Pneumonia nos	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Cellulitis	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Gastroenteritis nos	3.8% 2/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Bronchiolitis	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Bronchitis nos	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Colitis pseudomembranous	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Gastroenteritis viral nos	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Kawasaki's disease	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Lobar pneumonia nos	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Pneumonia viral nos	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Septic shock	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Sinusitis nos	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Staphylococcal abscess	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
General disorders Pyrexia	3.8% 2/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
General disorders Injection site abscess	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
General disorders Multi-organ failure	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Metabolism and nutrition disorders Metabolic disorder nos	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Metabolism and nutrition disorders Tetany	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Investigations Blood creatinine increased	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Investigations Blood urea increased	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Blood and lymphatic system disorders Neutropenia	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sweat gland tumour	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Nervous system disorders Dystonia	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Skin and subcutaneous tissue disorders Rash papular	1.9% 1/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.

Other adverse events

Measure	Enfuvirtide n=52 participants at risk 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).
Infections and infestations Upper respiratory tract infection nos	42.3% 22/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Otitis media nos	23.1% 12/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Nasopharyngitis	17.3% 9/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Sinusitis nos	15.4% 8/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Oral candidiasis	11.5% 6/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Body tinea	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Impetigo nos	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Viral infection nos	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Gastroenteritis nos	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Herpes simplex	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Infections and infestations Herpes zoster	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 13/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Respiratory, thoracic and mediastinal disorders Bronchospasm nos	11.5% 6/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.5% 6/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic nos	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Respiratory, thoracic and mediastinal disorders Asthma nos	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Respiratory, thoracic and mediastinal disorders Wheezing	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Gastrointestinal disorders Nausea	21.2% 11/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Gastrointestinal disorders Vomiting nos	21.2% 11/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Gastrointestinal disorders Diarrhoea nos	17.3% 9/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Gastrointestinal disorders Abdominal pain nos	13.5% 7/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Gastrointestinal disorders Abdominal pain upper	11.5% 6/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Gastrointestinal disorders Loose stools	9.6% 5/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Gastrointestinal disorders Sore throat nos	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Gastrointestinal disorders Mouth ulceration	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Skin and subcutaneous tissue disorders Dermatitis Nos	19.2% 10/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Skin and subcutaneous tissue disorders Acne Nos	9.6% 5/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Skin and subcutaneous tissue disorders Eczema Seborrhoeic	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Skin and subcutaneous tissue disorders Rash papular	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
General disorders Pyrexia	21.2% 11/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
General disorders Fatigue	11.5% 6/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Eye disorders Conjunctivitis nec	9.6% 5/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Eye disorders Conjunctivitis allergic	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Eye disorders Vision blurred	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Investigations Weight decreased	9.6% 5/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Investigations Haematuria present	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Blood and lymphatic system disorders Lymphadenopathy	13.5% 7/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Musculoskeletal and connective tissue disorders Arthralgia	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Musculoskeletal and connective tissue disorders Back Pain	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Nervous system disorders Headache Nos	11.5% 6/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Immune system disorders Hypersensitivity Nos	7.7% 4/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Ear and labyrinth disorders Earache	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Injury, poisoning and procedural complications Arthropod bite	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Metabolism and nutrition disorders Appetite decreased nos	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.
Renal and urinary disorders Dysuria	5.8% 3/52 • Up to Week 96 All participants who received at least one dose of study medication were included in safety analysis.

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

Email: global.trial_information@roche.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER