Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-29 @ 5:41 PM
Study NCT ID:
NCT02509195
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2015-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SSAT064: Pharmacokinetics of Abacavir/Lamivudine/Dolutegravir in HIV Patients of 60 Years and Over
Sponsor:
St Stephens Aids Trust
Organization:
Study Overview
Official Title:
An Open Label Study to Investigate the Safety and Efficacy of Abacavir/Lamivudine/Dolutegravir and the Pharmacokinetic Profile of Dolutegravir in HIV-infected Patients of 60 Years of Age and Older
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to identify the effects that ageing may have on the drug levels, the safety and the efficacy of Dolutegravir.
These effects will be measured in people who are aged 60 or over and taking antiretroviral therapy for HIV infection.
Dolutegravir is a newly licenced anti HIV medication, which belongs to a class of drugs called Integrase Inhibitors. It is taken with two other wellknown agents, Abacavir and Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data available on Dolutegravir in the context of older age. The HIV population is ageing and the investigators know that older age can significantly change the effects and side effects of medications, including that of antiretrovirals.
The investigators aim to investigate the treatment outcomes in older people taking Dolutegravir including the tolerability, efficacy and safety of the drug.
The study will also assess the quality of life (wellbeing of individuals) and cognition (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this study may inform treatment choices and monitoring in this population in the future.
The duration of involvement in the study will be 6 months with an additional screening visit and a checkup visit 10 days after end of study visit.
These effects will be measured in people who are aged 60 or over and taking antiretroviral therapy for HIV infection.
Dolutegravir is a newly licenced anti HIV medication, which belongs to a class of drugs called Integrase Inhibitors. It is taken with two other wellknown agents, Abacavir and Lamivudine, as part of a one tablet once a day regimen, called Triumeq. There is little data available on Dolutegravir in the context of older age. The HIV population is ageing and the investigators know that older age can significantly change the effects and side effects of medications, including that of antiretrovirals.
The investigators aim to investigate the treatment outcomes in older people taking Dolutegravir including the tolerability, efficacy and safety of the drug.
The study will also assess the quality of life (wellbeing of individuals) and cognition (mental abilities) of people aged 60 or over, taking Dolutegravir. The results from this study may inform treatment choices and monitoring in this population in the future.
The duration of involvement in the study will be 6 months with an additional screening visit and a checkup visit 10 days after end of study visit.
Detailed Description:
Protocol Number: SSAT 064
EudraCT Number: 2014-004970-40
Name of Investigational Product:Triumeq®
Name of active ingredients:Abacavir/lamivudine/dolutegravir
Study title: An open label study to investigate the safety and efficacy of abacavir/lamivudine/dolutegravir and the pharmacokinetic profile of dolutegravir in HIV-infected patients of 60 years of age and older
Objectives:
Primary:
* To assess the steady state pharmacokinetics of dolutegravir 50 mg once daily in HIV-infected subjects of 60 years or greater
Secondary:
* To assess the safety, tolerability, patient quality of life and sleep quality and maintenance of HIV viral load control of abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater
* To measure the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
* To investigate cerebral function via cognitive testing before and after a switch in antiretroviral therapy to dolutegravir containing regimens
* To investigate the relationship between genetic polymorphisms and exposure to dolutegravir
Study design:Multi -centre, 180 days (excluding screening and follow up), open label, prospective, one phase pharmacokinetic/pharmacodynamic study
Indication:HIV-1 infection
Methodology:HIV-1 infected subjects will be recruited from four different HIV clinics. Eligible subjects currently receiving stable antiretroviral therapy with an undetectable plasma HIV RNA and with no evidence of previous HIV resistance mutations on genotypic resistance testing, will switch their treatment to abacavir/lamivudine/dolutegravir and undergo a 24 hour pharmacokinetic assessment at day 28 (+/- 1). Monitoring of adverse events (not at screening), viral load, quality of life and sleep quality, will occur at screening and on days 1, 28, 90, and 180. Cognitive function will be tested at screening, baseline and day 180. A sleep diary will be completed between day 1 and day 28.
Planned sample size:A sample size of 40 patients would provide at least 80% power to detect changes in dolutegravir exposure in older people.
Up to 45 subjects may be screened to have 40 patients completing the study.
Summary of eligibility criteria:HIV-1 infected subjects currently receiving stable antiretroviral therapy with undetectable plasma HIV RNA and no evidence of previous HIV- resistance mutations on genotypic resistance testing, 60 years old or older (approximately 30% between 60 and 64 and approximately 70% above the age of 65)
Number of study centres: 4 centres:
Chelsea and Westminster Hospital, London Royal Sussex County Hospital, Brighton St. Mary's Hospital Clinical Trials Centre, London Mortimer Market Centre, UCL, London
Duration of treatment: 180 (+/- 7) days
Dose and route of administration: All study drugs will be administered orally to subjects with the following schedule: Abacavir/lamivudine/dolutegravir one pill once daily
Criteria for evaluation:
Pharmacokinetic parameters of dolutegravir will be evaluated on blood drawn on day 28 (+/- 1) at 0 (pre-dose), 1, 2, 3, 4, 8, 12 and 24 hours post dose.
Monitoring of adverse events (not at screening), viral load, quality of life and sleep quality will occur at screening and days 1, 28, 90, and 180. Cognitive function will be tested at screening, baseline and day 180.
Primary Endpoint:
* Steady state plasma concentrations of dolutegravir when administered to HIV-infected individuals over the age of 60/65 years.
Secondary Endpoints:
* Safety, tolerability, maintenance of HIV viral load control, quality of life and sleep quality with abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater
* Measurement of the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
* Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to dolutegravir containing regimens
* Relationship between genetic polymorphisms and exposure to dolutegravir.
EudraCT Number: 2014-004970-40
Name of Investigational Product:Triumeq®
Name of active ingredients:Abacavir/lamivudine/dolutegravir
Study title: An open label study to investigate the safety and efficacy of abacavir/lamivudine/dolutegravir and the pharmacokinetic profile of dolutegravir in HIV-infected patients of 60 years of age and older
Objectives:
Primary:
* To assess the steady state pharmacokinetics of dolutegravir 50 mg once daily in HIV-infected subjects of 60 years or greater
Secondary:
* To assess the safety, tolerability, patient quality of life and sleep quality and maintenance of HIV viral load control of abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater
* To measure the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
* To investigate cerebral function via cognitive testing before and after a switch in antiretroviral therapy to dolutegravir containing regimens
* To investigate the relationship between genetic polymorphisms and exposure to dolutegravir
Study design:Multi -centre, 180 days (excluding screening and follow up), open label, prospective, one phase pharmacokinetic/pharmacodynamic study
Indication:HIV-1 infection
Methodology:HIV-1 infected subjects will be recruited from four different HIV clinics. Eligible subjects currently receiving stable antiretroviral therapy with an undetectable plasma HIV RNA and with no evidence of previous HIV resistance mutations on genotypic resistance testing, will switch their treatment to abacavir/lamivudine/dolutegravir and undergo a 24 hour pharmacokinetic assessment at day 28 (+/- 1). Monitoring of adverse events (not at screening), viral load, quality of life and sleep quality, will occur at screening and on days 1, 28, 90, and 180. Cognitive function will be tested at screening, baseline and day 180. A sleep diary will be completed between day 1 and day 28.
Planned sample size:A sample size of 40 patients would provide at least 80% power to detect changes in dolutegravir exposure in older people.
Up to 45 subjects may be screened to have 40 patients completing the study.
Summary of eligibility criteria:HIV-1 infected subjects currently receiving stable antiretroviral therapy with undetectable plasma HIV RNA and no evidence of previous HIV- resistance mutations on genotypic resistance testing, 60 years old or older (approximately 30% between 60 and 64 and approximately 70% above the age of 65)
Number of study centres: 4 centres:
Chelsea and Westminster Hospital, London Royal Sussex County Hospital, Brighton St. Mary's Hospital Clinical Trials Centre, London Mortimer Market Centre, UCL, London
Duration of treatment: 180 (+/- 7) days
Dose and route of administration: All study drugs will be administered orally to subjects with the following schedule: Abacavir/lamivudine/dolutegravir one pill once daily
Criteria for evaluation:
Pharmacokinetic parameters of dolutegravir will be evaluated on blood drawn on day 28 (+/- 1) at 0 (pre-dose), 1, 2, 3, 4, 8, 12 and 24 hours post dose.
Monitoring of adverse events (not at screening), viral load, quality of life and sleep quality will occur at screening and days 1, 28, 90, and 180. Cognitive function will be tested at screening, baseline and day 180.
Primary Endpoint:
* Steady state plasma concentrations of dolutegravir when administered to HIV-infected individuals over the age of 60/65 years.
Secondary Endpoints:
* Safety, tolerability, maintenance of HIV viral load control, quality of life and sleep quality with abacavir/lamivudine/dolutegravir once daily in HIV-infected subjects of 60 years or greater
* Measurement of the metabolic profile in patients over the age of 60 with HIV infection who switch antiretroviral regime (metabonomics)
* Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to dolutegravir containing regimens
* Relationship between genetic polymorphisms and exposure to dolutegravir.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-004970-40 | EUDRACT_NUMBER | None | View |