Changes to trial information |
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Trial Information |
Trial phase |
16/11/2018 |
This is a phase I/II study and the study will start with the phase I part and will only proceed to phase II once data from phase I are available |
Phase-2 |
Phase-1 |
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Trial Information |
Anticipated trial start date |
15/08/2019 |
Delay in product manufacture |
01 Feb 2019 |
01 Oct 2019 |
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Trial Information |
Anticipated trial start date |
03/09/2019 |
Delay in product manufacture |
01 Oct 2019 |
01 Nov 2019 |
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Anticipated trial start date |
14/12/2019 |
Delay in manufacturing |
01 Nov 2019 |
27 Feb 2020 |
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Trial Information |
Actual trial start date |
06/08/2020 |
Trial open for screening on 9 Jul 2020 |
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09 Jul 2020 |
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Trial Information |
Recruitment status |
06/08/2020 |
First participant enrolled 4 August 2020 |
Not yet recruiting |
Recruiting |
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Date
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Trial Information |
Recruitment status |
27/06/2022 |
Pending review of PK and safety data |
Recruiting |
Suspended |
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Eligibility |
Age group |
25/09/2018 |
correction |
Adult: 19 Year-44 Year |
Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year |
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Intervention |
Intervention List |
10/12/2021 |
Align with protocol |
Experimental Group, tenofovir alafenamide, TAF 110mg is formulated in a sub-dermal implant, releasing a daily dose of 0.25mg. , Maximum of 120 weeks (116 weeks on product and 4 weeks off product), A total of 1, 2, 3 or 4 implants will be inserted, in the inside of the upper arm, to achieve and test the target daily release of 0.25mg, 0.5mg, 0.75mg and 1mg of TAF, respectively. The number of implants, implant location and replacement interval for the phase II component of the trial will be determined from the phase I data. The intervention group will receive the TAF impant plus oral placebo tablets, 245, |
Experimental Group, tenofovir alafenamide, TAF 110mg is formulated in a sub-dermal implant, releasing a daily dose of 0.25mg. , Maximum of 120 weeks (116 weeks on product and 4 weeks off product), A total of 1, 2, 3 or 4 implants will be inserted, in the inside of the upper arm, to achieve and test the target daily release of 0.25mg, 0.5mg, 0.75mg and 1mg of TAF, respectively. The number of implants, implant location and replacement interval for the phase II component of the trial will be determined from the phase I data. The intervention group will receive the TAF impant plus oral placebo tablets, 490, |
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Intervention |
Intervention List |
10/12/2021 |
Align with protocol |
Experimental Group, tenofovir alafenamide, TAF 110mg is formulated in a sub-dermal implant, releasing a daily dose of 0.25mg. , Maximum of 120 weeks (116 weeks on product and 4 weeks off product), A total of 1, 2, 3 or 4 implants will be inserted, in the inside of the upper arm, to achieve and test the target daily release of 0.25mg, 0.5mg, 0.75mg and 1mg of TAF, respectively. The number of implants, implant location and replacement interval for the phase II component of the trial will be determined from the phase I data. The intervention group will receive the TAF impant plus oral placebo tablets, 490, |
Experimental Group, tenofovir alafenamide, TAF 110mg is formulated in a sub-dermal implant, releasing a daily dose of 0.25mg. , Maximum of 120 weeks (116 weeks on product and 4 weeks off product), A total of 1, 2, 3 or 4 implants will be inserted, in the inside of the upper arm, to achieve and test the target daily release of 0.25mg, 0.5mg, 0.75mg and 1mg of TAF, respectively. The number of implants, implant location and replacement interval for the phase II component of the trial will be determined from the phase I data. The intervention group will receive the TAF impant plus oral placebo tablets, 245, |
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Intervention |
Intervention List |
10/12/2021 |
Aligned with protocol |
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Experimental Group, Tenofovir alafenamide implant , 110mg, From 28 days (Group 1) to 48 weeks (Group 2 and 3), This Phase I part of the trial assess safety and tolerability with dose escalation, where between 1 to 4 implants will be inserted. The initial safety assessment occurs in six participants (Group 1) followed by a dose escalation component (Groups 2, n=30 and 3, n=24) assessing the safety and PK of TAF 110mg implants releasing a daily dose of 0.25mg (1 implant), 0.5mg (2 implants), 0.75mg (3 implants) and 1mg (4 implants) in healthy, low risk, HIV-negative women. Comparator drugs include TAF 25mg oral tablets and the placebo implant. Once data from Groups 1 to 3 are available, the phase II component (Group 4, n=490) of the trial will be initiated, 60, |
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Outcome |
OutCome List |
10/12/2021 |
Aligned with study protocol |
Secondary Outcome, non-compartmental PK model, Daily for first 7 days post insertion then weekly thereafter until week 8 |
Secondary Outcome, To assess systemic and genital compartment PK of single and multiple TAF 110mg implant/s to determine in-human release rate characteristics, including to compare the PK profiles of insertion of two implants in one arm versus insertion of one implant in each arm.
, Intensive PK on the day of enrollment and thereafter samples collected at each scheduled visit , depending on Group assigned, until study exit |
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Outcome |
OutCome List |
10/12/2021 |
Aligned with protocol |
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Secondary Outcome, To assess the incidence of sexually transmitted infections (STIs), including (but not limited to) herpes simplex virus type 2 (HSV-2), human papillomavirus (HPV), gonorrhoea, chlamydia and trichomonas infections.
, All visits |