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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_008 | Other Identifier | Merck |
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This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of STOCRIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with HIV-1 infection taking Stocrin |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients with any adverse experience | Up to 14 days following cessation of treatment | |
| Proportion of patients with HIV-1 RNA levels of less than 400 copies per milliliter after treatment | At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment | |
| Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure or can not be assessed) | At 12 weeks +/- 2 weeks and at 24 weeks +/- 2 weeks after first treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HIV-1 infection treated with STOCRIN
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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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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| 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 |