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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022907-23 | EudraCT Number |
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This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited, subjects will switch antiretroviral therapy to:
This is a phase IV, open label, prospective, one phase pharmacokinetic and observational study.
Twenty HIV-1 infected subjects will be recruited. Eligible subjects will currently be receiving stable antiretroviral therapy with undetectable plasma HIV RNA and have no evidence of previous HIV- resistance mutations on genotypic resistance testing.
At baseline, subjects will switch antiretroviral therapy to:
Follow up over 6 months, subjects will attend on days 14, 90 and 180 for follow up visits that will include standard safety parameters. Assessment of cardiac biomarkers at baseline and on days 90 and 180 and assessment of neurocognitive function at screening, baseline and on day 180 will also be undertaken.
Following completion of this study, subjects will recommence their usual antiretroviral treatment regimen and attend for a study follow up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir/Emtricitabine and Raltegravir | Other | Single arm study tenofovir/emtricitabine 245/200 mg once daily and raltegravir 400 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | 400 mg twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug Levels in Blood | rategravir concentration | Day 28 |
| Changes in Haematology, Biochemistry and Virology Tests | full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Disease Markers | • To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir. | 6 months |
| Cerebral Function; Changes in Global Cognitive Z-score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Winston, MB BH | Imperial College London | Principal Investigator |
| Marta Boffito | Chelsea & Westminster Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea & Westminster Hospital NHS Trust | London | SW10 9TH | United Kingdom | |||
| Imperial College Healthcare NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25777188 | Result | Vera JH, Jackson A, Dickinson L, Else L, Barber T, Mora-Peris B, Back D, Boffito M, Winston A. The pharmacokinetic profile of raltegravir-containing antiretroviral therapy in HIV-infected individuals over 60 years of age. HIV Clin Trials. 2015 Jan-Feb;16(1):39-42. doi: 10.1179/1528433614Z.0000000006. Epub 2015 Jan 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Truvada Plus Raltegravir | Single arm study Raltegravir: 400 mg twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Truvada Plus Raltegravir | Single arm study Raltegravir: 400 mg twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drug Levels in Blood | rategravir concentration | Posted | Geometric Mean | 95% Confidence Interval | ng/ml | Day 28 |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Truvada Plus Raltegravir | Single arm study Raltegravir: 400 mg twice daily | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Winston | Imperial College London | +442033121603 | 21603 | a.winston@imperial.ac.uk |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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HIV affected over 60 years old
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| Tenofovir | Drug | 245 mg once daily |
|
| Emtricitabine | Drug | 200mg once daily |
|
Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.
Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion.
| 6 months |
| London |
| W2 1NY |
| United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Changes in Haematology, Biochemistry and Virology Tests | full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus | No data collected | Posted | 6 months |
|
|
| Secondary | Cardiovascular Disease Markers | • To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir. | No data collected | Posted | 6 months |
|
|
| Secondary | Cerebral Function; Changes in Global Cognitive Z-score | Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir. Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
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| D063065 |
| Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |