Clinical Trial Results:
A Rollover Protocol to Provide Subjects Completing the FTC-203 Study in South Africa with Continued Access to Emtricitabine
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Summary
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EudraCT number |
2015-000304-26 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
13 Feb 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Aug 2017
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First version publication date |
27 Aug 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GS-US-162-0112
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00743340 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Gilead Sciences
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Sponsor organisation address |
333 Lakeside Drive, Foster City, CA, United States, 94404
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Public contact |
Clinical Trials Mailbox, Gilead Sciences International Ltd., ClinicalTrialDisclosures@gilead.com
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Scientific contact |
Clinical Trials Mailbox, Gilead Sciences International Ltd., ClinicalTrialDisclosures@gilead.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Feb 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Feb 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Feb 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The objectives of this trial were to provide FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine, following completion of the FTC-203 study and to collect long-term safety information in participants receiving emtricitabine in combination with other antiretroviral agents.
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Protection of trial subjects |
The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements.
This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Nov 2005
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
South Africa: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
43
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Adolescents (12-17 years) |
7
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
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. | ||||||||||||||||||||||||
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Pre-assignment
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Screening details |
59 participants were screened. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||
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Arms
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Arm title
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Emtricitabine | ||||||||||||||||||||||||
Arm description |
Emtricitabine administered once daily | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Emtricitabine
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Investigational medicinal product code |
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Other name |
FTC, Emtriva®
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Pharmaceutical forms |
Capsule, Oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
6 mg/kg capsule, up to a maximum of 200 mg once daily, or 10 mg/mL oral solution, up to a maximum of 240 mg once daily
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Baseline characteristics reporting groups
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Reporting group title |
Emtricitabine
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Reporting group description |
Emtricitabine administered once daily | |||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Emtricitabine
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Reporting group description |
Emtricitabine administered once daily | ||
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End point title |
Number of Participants Who Had Access to, and Received the Intervention [1] | ||||||||
End point description |
This endpoint has been included to satisfy the requirements of EU-CTR. However, there were no prespecified endpoints in this study.
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End point type |
Primary
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End point timeframe |
Up to 586 weeks
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical comparison was planned or performed. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Up to 586 weeks + 30 days
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Adverse event reporting additional description |
1) Safety Analysis Set: all enrolled participants who have received at least 1 dose of study drug
2) 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.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
Emtricitabine
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Reporting group description |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Nonserious/other adverse events were not collected for this study. |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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24 Jul 2013 |
• Update of the Medical Monitor of the study
• Clarified the location of the sponsor
•Clarification that potential genotypic analysis samples needed will not be shipped to Gilead Sciences, Inc.
•Update to the Principle Investigator at the Infectious Disease Clinical Trial Unit study center
•Clarification to the clinic visits in which subject height and weight is to be taken.
•Update to Study Procedures Table, to clarify that HIV-1 Viral RNA levels are to be taken at every visit, and to clarify when subject height and weight should be measured
•Update to the acceptable methods of contraception requirements in the Inclusion Criteria
•Update to the date of the mentioned Investigator’s Brochure for emtricitabine to the eleventh edition, dated 30 June 2010
•Update to the storage and handling requirements for emtricitabine oral solution
•Update of the safety reporting of Special Situations based on CT3 Guidance from the European Commission
•Update to the contraception requirements for the study based on current recommendations for use with emtricitabine
•Update to Emtricitabine (Emtriva®) Dose Tables to reflect the current dosing guidelines recommended for Emtricitabine capsules, 200mg.
•Updated current GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
