Trial Outcomes & Findings for Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine (NCT NCT00743340)
NCT ID: NCT00743340
Last Updated: 2018-04-26
Results Overview
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 586 weeks
Results posted on
2018-04-26
Participant Flow
Participants were enrolled at 2 study sites in South Africa. The first participant was screened on 22 November 2005. The last study visit occurred on 13 February 2017.
59 participants were screened.
Participant milestones
| Measure |
Emtricitabine
Emtricitabine (FTC) 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Emtricitabine
Emtricitabine (FTC) 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
|
|---|---|
|
Overall Study
Study medication non-compliance
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal from the Study
|
5
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Virologic failure
|
8
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Rolled over to other Gilead Study
|
23
|
|
Overall Study
Participant Relocated
|
1
|
Baseline Characteristics
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
Baseline characteristics by cohort
| Measure |
Emtricitabine
n=50 Participants
Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
|
|---|---|
|
Age, Continuous
|
8 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 586 weeksPopulation: Participants who were enrolled into the study and received study drug.
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study.
Outcome measures
| Measure |
Emtricitabine
n=50 Participants
Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
|
|---|---|
|
Number of Participants Who Had Access to, and Received the Intervention
|
50 Participants
|
Adverse Events
Emtricitabine
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Emtricitabine
n=50 participants at risk
Emtricitabine 6 mg/kg capsule once daily, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
|
|---|---|
|
Vascular disorders
Essential hypertension
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
4.0%
2/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Injury, poisoning and procedural complications
Overdose
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Investigations
Weight decreased
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
General disorders
Swelling
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Psychiatric disorders
Conduct disorder
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Psychiatric disorders
Reactive attachment disorder of infancy or early childhood
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Reproductive system and breast disorders
Breast enlargement
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Infections and infestations
Appendicitis
|
4.0%
2/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
|
Infections and infestations
Post procedural sepsis
|
2.0%
1/50 • Up to 586 Weeks + 30 days
* Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug * One participant who resulted in incomplete abortion (System order class: Pregnancy, puerperium and perinatal conditions; Event term: Abortion incomplete) was not counted as part of SAE but was counted under pregnancies.
|
Other adverse events
Adverse event data not reported
Additional Information
Clinical Trial Disclosures & Data Transparency
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER