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The purpose of the study is to look at whether changing directly from one medication for HIV (efavirenz) to a new medication for HIV (TMC125) has any effect on the levels of TMC125 in the blood, compared to when TMC125 is taken without efavirenz having been taken immediately beforehand.
The study aims to help the investigators understand whether it is safe to change directly from efavirenz to TMC125 (with no gap between the treatments) in patients who need these treatments.
The study will investigate the blood levels of TMC125 when it is taken both once and twice a day.
Pharmacokinetic parameters of TMC125 will be evaluated when TMC125 is given without and with a 14-day efavirenz intake preceding period in order to evaluate the risk of achieving sub therapeutic concentrations of TMC125 when switching straight from efavirenz containing regimens
Safety and tolerability of medications will also be assessed by questions, physical examination and laboratory parameters. These will be performed at regular intervals during the drug study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily |
|
| 2 | Other | Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC125 once daily | Drug | Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily |
| Measure | Description | Time Frame |
|---|---|---|
| Steady state plasma concentrations of TMC125 administered once and twice-daily and following a 2-week-treatment period with efavirenz 600 mg once daily | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Efavirenz inducing effect on TMC125 metabolism after efavirenz intake cessation evaluation. Safety and tolerability of TMC125 administered once and twice-daily | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Boffito | Chelsea & Westminser Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Stephens Centre, Chelsea & Westminster Hospital | London | SW10 9th | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 19, 2009 | |
| Reset | Nov 19, 2009 | |
| Release | Nov 23, 2009 | |
| Reset | Dec 29, 2009 | |
| Release | Jan 11, 2010 | |
| Reset | Feb 1, 2010 | |
| Release | Aug 25, 2010 | |
| Reset | Sep 17, 2010 | |
| Release | Mar 7, 2011 | |
| Reset | Apr 5, 2011 | |
| Release | Apr 6, 2011 | |
| Reset | May 5, 2011 | |
| Release | May 6, 2011 | |
| Reset | Jun 6, 2011 | |
| Release | Jul 5, 2011 | |
| Reset | Aug 1, 2011 | |
| Release | Jun 6, 2012 | |
| Reset | Jul 6, 2012 | |
| Release | Oct 4, 2012 | |
| Reset | Nov 2, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 19, 2009 | Nov 19, 2009 | |||
| Nov 23, 2009 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| TMC125 twice daily | Drug | Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily |
|
| Dec 29, 2009 |
| Jan 11, 2010 | Feb 1, 2010 |
| Aug 25, 2010 | Sep 17, 2010 |
| Mar 7, 2011 | Apr 5, 2011 |
| Apr 6, 2011 | May 5, 2011 |
| May 6, 2011 | Jun 6, 2011 |
| Jul 5, 2011 | Aug 1, 2011 |
| Jun 6, 2012 | Jul 6, 2012 |
| Oct 4, 2012 | Nov 2, 2012 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |