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The primary purpose of this study is to determine if dronabinol is effective in preventing or treating nausea caused by HAART (highly active anti-retroviral therapy) in HIV and AIDS patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | 2.5 mg to 40 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of episodes vomiting/retching | 2 weeks | |
| Duration of nausea, vomiting/retching | 2 weeks | |
| Intensity of nausea by VAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 911 | Bakersfield | California | United States | |||
| Site 919 |
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| Drug |
placebo |
|
| 2 weeks |
| Appetite stimulation by VAS | 2 weeks |
| Fresno |
| California |
| United States |
| Site 924 | Los Angeles | California | United States |
| Site 932 | Los Angeles | California | United States |
| Site 926 | Palm Springs | California | United States |
| Site 946 | Pasadena | California | United States |
| Site 913 | Tarzana | California | United States |
| Site 907 | Altamonte Springs | Florida | United States |
| Site 948 | Miami | Florida | United States |
| Site 951 | Miami | Florida | United States |
| Site 953 | Miami | Florida | United States |
| Site 959 | Miami | Florida | United States |
| Site 954 | North Palm Beach | Florida | United States |
| Site 957 | Pensacola | Florida | United States |
| Site 923 | Port Saint Lucie | Florida | United States |
| Site 929 | Sarasota | Florida | United States |
| Site 952 | Tallahassee | Florida | United States |
| Site 931 | Tampa | Florida | United States |
| Site 908 | Decatur | Georgia | United States |
| Site 905 | Boise | Idaho | United States |
| Site 914 | Chicago | Illinois | United States |
| Site 928 | Louisville | Kentucky | United States |
| Site 955 | Louisville | Kentucky | United States |
| Site 958 | New Orleans | Louisiana | United States |
| Site 934 | Boston | Massachusetts | United States |
| Site 915 | Springfield | Missouri | United States |
| Site 956 | Somers Point | New Jersey | United States |
| Site 921 | Albany | New York | United States |
| Site 910 | Cincinnati | Ohio | United States |
| Site 941 | Philadelphia | Pennsylvania | United States |
| Site 925 | Dallas | Texas | United States |
| Site 917 | Fort Worth | Texas | United States |
| Site 906 | Houston | Texas | United States |
| Site 942 | Houston | Texas | United States |
| Site 909 | Tacoma | Washington | United States |
| Site 927 | Vancouver | Washington | United States |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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