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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_001 | 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 Isentress through collecting the safety and efficacy information in usual practice 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 | HIV-1 Infected patients treated with Isentress |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment | up to 14 days after last treatment | |
| Proportions of patients with HIV-1 RNA levels of less than 50 milliliter | 6 months after treatment +/- 2 weeks | |
| Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter | 6 months after treatment +/- 2 weeks | |
| Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible) | 6 months after treatment +/- 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-1 Infected adults
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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 |