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We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| efavirenz | Active Comparator |
| |
| over-encapsulated efavirenz | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz | Drug | Subject will take efavirenz for 5 days. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Efavirenz | Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz. | 5th day of taking drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy W Schacker, M.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Efavirenz First, Then Over-encapsulated Efavirenz | This arm received efavirenz for five days, then over-encapsulated efavirenz for five days. |
| FG001 | Over-encapsulated Efavirenz First, Then Efavirenz | This arm received over-encapsulated efavirenz for five days, then efavirenz for five days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (5 Days) |
|
| ||||||||||||||||||
| Second Intervention (5 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Efavirenz | Both arms received both versions of the drug during the course of the study. |
| BG001 | Over-encapsulated Efavirenz | Both arms received both versions of the drug over the course of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Serum Levels of Efavirenz | Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz. | Posted | Mean | Standard Deviation | ng/mL | 5th day of taking drug |
|
|
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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 | Efavirenz | Both arms received both versions of the drug during the course of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Seguin | University of Minnesota | 612-625-7472 | segu0017@umn.edu |
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| 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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| ID | Term |
|---|---|
| C098320 | efavirenz |
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| Over-encapsulated efavirenz | Drug | Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days. |
|
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Over-encapsulated Efavirenz | Both arms received both versions of the drug over the course of the study. | 0 | 7 | 0 | 7 |
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| 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 |