Changes to trial information |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Actual trial start date |
13/07/2022 |
Regulatory approval of the trial and shipping of the investigational product took longer than anticipated |
|
01 Feb 2022 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
|
Trial Information |
Anticipated date of last follow up |
13/07/2022 |
Delayed start of the trial |
06 Jan 2023 |
01 Aug 2023 |
Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
|
Trial Information |
Anticipated date of last follow up |
11/08/2023 |
Study follow-up period was extended to 96 weeks |
01 Aug 2023 |
02 Jan 2024 |
Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
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Trial Information |
Completion date |
25/10/2024 |
Updated |
|
18 Mar 2024 |
Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
|
Trial Information |
Final no of participants |
13/07/2022 |
Protocol allowed enrolment upto 520 participants so as to ensure each arm had 258 participants |
|
520 |
Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
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Trial Information |
Recruitment status |
13/07/2022 |
Recruitment completed |
Not yet recruiting |
Closed to recruitment,follow-up continuing |
Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
13/06/2024 |
Completed 96 weeks of follow-up |
Closed to recruitment,follow-up continuing |
Completed |
Section Name
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Field Name
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Date
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Reason
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Old Value
|
Updated Value
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Intervention |
Intervention List |
11/08/2023 |
Study follow-up period extended to 96 weeks |
|
Experimental Group, Switch to BFTAF, B/F/TAF will be administered as a single tablet fixed-dose combination of BIC/FTC/TAF (50mg/200mg/25mg) once daily, 96 weeks, On the day of enrollment, subjects will be randomized to continue their pre-enrollment ARV regimen or switch to B/F/TAF. Those who are randomized to switch to B/F/TAF will be provided with a once-daily tablet that is a combination of bictegravir, emtricitabine and tenofovir alafenamide (BIC/FTC/TAF - 50mg/200mg/25mg) and followed up for 96 weeks , 260, |
Section Name
|
Field Name
|
Date
|
Reason
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Old Value
|
Updated Value
|
Intervention |
Intervention List |
11/08/2023 |
Study follow-up period extended to 96 weeks |
Experimental Group, Switch to BFTAF, B/F/TAF will be administered as a single tablet fixed-dose combination of BIC/FTC/TAF (50mg/200mg/25mg) once daily, 48 weeks, On the day of enrollment, subjects will be randomized to continue their pre-enrollment ARV regimen or switch to B/F/TAF. Those who are randomized to switch to B/F/TAF will be provided with a once-daily tablet that is a combination of bictegravir, emtricitabine and tenofovir alafenamide (BIC/FTC/TAF - 50mg/200mg/25mg) and followed up for 48 weeks , 258, |
Experimental Group, Switch to BFTAF, B/F/TAF will be administered as a single tablet fixed-dose combination of BIC/FTC/TAF (50mg/200mg/25mg) once daily, 96 weeks, On the day of enrollment, subjects will be randomized to continue their pre-enrollment ARV regimen or switch to B/F/TAF. Those who are randomized to switch to B/F/TAF will be provided with a once-daily tablet that is a combination of bictegravir, emtricitabine and tenofovir alafenamide (BIC/FTC/TAF - 50mg/200mg/25mg) and followed up for 48 weeks , 260, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
11/08/2023 |
Study follow-up period extended to 96 weeks |
Control Group, Continue with current ARV Regimen, This will depend on the regimen the subject is using, for example:
- if on TDF/3TC/EFV will receive one tablet once a day
- if on TDF/3TC/DTG will receive one tablet once a day
- if on AZT/3TC+DTG will receive one tablet of AZT/3TC twice a day and a tablet of DTG once a day , 48 weeks, On the day of enrollment, subjects will be randomized to continue their pre-enrollment ARV regimen or switch to B/F/TAF. Those who are randomized to continue with their current ARV regimen will receive the first-line ARVs they were on at the time of enrollment for the 48-week follow-up period., 258, Active-Treatment of Control Group |
Control Group, Continue with current ARV Regimen, This will depend on the regimen the subject is using, for example:
- if on TDF/3TC/EFV will receive one tablet once a day
- if on TDF/3TC/DTG will receive one tablet once a day
- if on AZT/3TC+DTG will receive one tablet of AZT/3TC twice a day and a tablet of DTG once a day , 96 weeks, On the day of enrollment, subjects will be randomized to continue their pre-enrollment ARV regimen or switch to B/F/TAF. Those who are randomized to continue with their current ARV regimen will receive the first-line ARVs they were on at the time of enrollment for the 96-week follow-up period., 260, Active-Treatment of Control Group |
Section Name
|
Field Name
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Date
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Reason
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Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
The primary outcome will only be assessed at week 48 |
Primary Outcome, To evaluate the non-inferiority of switching to B/F/TAF, compared to maintaining the current ARV regimen, in virologically suppressed HIV-1 positive elderly adults (≥ 60 years) with no prior confirmed virological failure, as determined by HIV-1 RNA PCR ≥ 50 copies/ml at week 48, Weeks 24 and 48 |
Primary Outcome, To evaluate the non-inferiority of switching to B/F/TAF, compared to maintaining the current ARV regimen, in virologically suppressed HIV-1 positive elderly adults (≥ 60 years) with no prior confirmed virological failure, as determined by HIV-1 RNA PCR ≥ 50 copies/ml at week 48, Weeks 48 |
Section Name
|
Field Name
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Date
|
Reason
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Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
The primary outcome will only be assessed at week 48 |
Primary Outcome, To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in lumbar spine bone mineral density (BMD) after 48 weeks as measured by dual-energy x-ray absorptiometry (DXA), Weeks 24 and 48 |
Primary Outcome, To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in lumbar spine bone mineral density (BMD) after 48 weeks as measured by dual-energy x-ray absorptiometry (DXA), Weeks 48 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
Study extended to 96 weeks |
Secondary Outcome, To assess the impact of switching to B/F/TAF on development of virological failure at week 24, Week 24 |
Secondary Outcome, To assess the impact of switching to B/F/TAF on development of virological failure at week 24 and 96, Week 24 and 96 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
Study extended to 96 weeks |
Secondary Outcome, To assess the impact of switching to B/F/TAF on maintenance of virological suppression at weeks 24 and 48, Weeks 24 and 48 |
Secondary Outcome, To assess the impact of switching to B/F/TAF on maintenance of virological suppression at weeks 24, 48 and 96, Weeks 24, 48 and 96 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
Study extended to 96 weeks |
Secondary Outcome, To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in lumbar spine BMD at week 24, Week 24 |
Secondary Outcome, To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in lumbar spine BMD at week 24 and 96, Week 24 and 96 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
Study extended to 96 weeks |
Secondary Outcome, To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in total hip BMD at weeks 24 and 48, Week 24 and 48 |
Secondary Outcome, To evaluate the effect of B/F/TAF relative to maintaining the current ARV regimen on percentage change in total hip BMD at weeks 24, 48 and 96, Week 24, 48 and 96 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
Study extended to 96 weeks |
Secondary Outcome, To evaluate the impact of switching to B/F/TAF on Fracture Risk Assessment Tool (FRAX) score at weeks 24 and 48, Weeks 24 and 48 |
Secondary Outcome, To evaluate the impact of switching to B/F/TAF on Fracture Risk Assessment Tool (FRAX) score at weeks 24, 48 and 96, Weeks 24, 48 and 96 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
Study extended to 96 weeks |
Secondary Outcome, To evaluate the impact of switching to B/F/TAF on patient satisfaction as measured by the HIV Treatment Satisfaction Questionnaire (HIVTSQ) at weeks 24 and 48, Weeks 24 and 48 |
Secondary Outcome, To evaluate the impact of switching to B/F/TAF on patient satisfaction as measured by the HIV Treatment Satisfaction Questionnaire (HIVTSQ) at weeks 24, 48 and 96, Weeks 24, 48 and 96 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
Study extended to 96 weeks |
Secondary Outcome, To assess the impact of switching to B/F/TAF on change in CD4 count at weeks 24 and 48, Weeks 24 and 48 |
Secondary Outcome, To assess the impact of switching to B/F/TAF on change in CD4 count at weeks 24, 48 and 96, Weeks 24, 48 and 96 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Outcome |
OutCome List |
14/08/2023 |
Study extended to 96 weeks |
Secondary Outcome, To assess the impact of switching to B/F/TAF on renal function at weeks 24 and 48, Weeks 24 and 48 |
Secondary Outcome, To assess the impact of switching to B/F/TAF on renal function at weeks 24, 48 and 96, Weeks 24, 48 and 96 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to the review comments |
|
Loice Achieng, College of Health Sciences, University of Nairobi, Nairobi, 00202, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Jeremy Penner, College of Health Sciences, University of Nairobi, Nairobi, 00202, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Jared Mecha, College of Health Sciences, University of Nairobi, Nairobi, 00202, Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Anton Pozniak, Chelsea and Westminster Hospital NHS Foundation, London, , United Kingdom |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Sanjay Bhagani, Royal Free London NHS Foundation Trust , London, , United Kingdom |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Susan Njogo, National AIDS and STIs Control Program, Kenya, Nairobi, , Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Simon Wahome, Kenyatta National Hospital, Nairobi, , Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Sheila Eshiwani, Kenyatta National Hospital, Nairobi, , Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Ruth Wanjohi, Nairobi Hospital, Nairobi, , Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Florentius Ndinya, Jaramogi Oginga Odinga Teaching and Referral Hospital , Kisumu, , Kenya |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Rukia Aksam, Jaramogi Oginga Odinga Teaching and Referral Hospital, Kisumu, , Kenya |
Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
14/04/2021 |
Response to review comments |
|
Joseph Nkuranga, College of Health Sciences, University of Nairobi, Nairobi, , Kenya |