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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004026-98 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen-Cilag Ltd. | INDUSTRY |
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This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.
To investigate the following parameters in HIV-infected patients switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine for 60 days:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rilpivirine and Truvada | Experimental | TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rilpivirine | Drug | Rilpivirine 26mg |
|
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| Measure | Description | Time Frame |
|---|---|---|
| CSF:Plasma Ratio of Rilpivirine Levels | The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure | Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With HIV Viral Load Above 50 Copies Per mL | Plasma viral load will be measured at all study visits to assess if viral load is above the lower limit of detection (50 copies mL) | Day 3,14, 28, 60, 80-100 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Winston, MBChB MD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rilpivirine and Truvada | TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rilpivirine and Truvada | TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg 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 | CSF:Plasma Ratio of Rilpivirine Levels | The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure | Posted | Geometric Mean | 95% Confidence Interval | ratio expressed as a percentage | Day 60 |
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Duration of the study
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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 | Rilpivirine and Truvada | TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily Rilpivirine: Rilpivirine 26mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Borja Mora Peris | Imperial College London | 020 3312 6789 | b.mora-peris@imperial.ac.uk |
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| ID | Term |
|---|---|
| D000068696 | Rilpivirine |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Rilpivirine CSF concentration | Geometric Mean | Full Range | ng/mL |
|
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| Secondary | Number of Subjects With HIV Viral Load Above 50 Copies Per mL | Plasma viral load will be measured at all study visits to assess if viral load is above the lower limit of detection (50 copies mL) | Posted | Number | participants | Day 3,14, 28, 60, 80-100 |
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| 0 |
| 13 |
| 3 |
| 13 |
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| D006571 |
| Heterocyclic Compounds |