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| ID | Type | Description | Link |
|---|---|---|---|
| AI050410 (#9p30) | Other Identifier | Merck |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this research study is to learn about the birth control pill called LoFemenal in HIV+ and HIV negative women who live in Malawi. This is a pilot study to determine the effect of antiretroviral therapy on the pharmacokinetics of the most commonly used oral contraceptive in HIV+ women; and to measure ovulation suppression in women taking the oral contraceptive pill and antiretroviral therapy at the same time. Nine women will be enrolled and will be followed for a total of 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV+ARV+ | |||
| HIV+ARV- | |||
| HIV negative |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of women who complete the study | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion criteria for the 3 HIV+ women on antiretroviral therapy:
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9 women with known HIV status who have regular monthly menses.
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen S Stuart, MD, MPHTM | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Project Malawi | Lilongwe | Malawi |
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