HIV Infections Clinical Trial
Official title:
A Double-Blind, Randomized, Parallel-Group, Pilot Study of Oral Dronabinol Versus Placebo in the Treatment or Prevention of Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting
| Verified date | March 2008 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | April 2005 |
| Est. primary completion date | April 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Adherence to prior or current HAART was or is being compromised, or HAART was discontinued/interrupted due to nausea/vomiting; or beginning HAART or switching from a regimen at the time of screening for this study that did not produce significant nausea and/or vomiting to a regimen with zidovudine or a protease inhibitor (with or without low dose ritonavir). Exclusion Criteria: - Subjects with recent (within 30 days of randomization) or current opportunistic infection or neoplasm characteristic of AIDS (Category C of the CDC Classification System for HIV-1 infection, 1993 Revised Version). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 921 | Albany | New York |
| United States | Site 907 | Altamonte Springs | Florida |
| United States | Site 911 | Bakersfield | California |
| United States | Site 905 | Boise | Idaho |
| United States | Site 934 | Boston | Massachusetts |
| United States | Site 914 | Chicago | Illinois |
| United States | Site 910 | Cincinnati | Ohio |
| United States | Site 925 | Dallas | Texas |
| United States | Site 908 | Decatur | Georgia |
| United States | Site 917 | Fort Worth | Texas |
| United States | Site 919 | Fresno | California |
| United States | Site 906 | Houston | Texas |
| United States | Site 942 | Houston | Texas |
| United States | Site 924 | Los Angeles | California |
| United States | Site 932 | Los Angeles | California |
| United States | Site 928 | Louisville | Kentucky |
| United States | Site 955 | Louisville | Kentucky |
| 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 | N. Palm Beach | Florida |
| United States | Site 958 | New Orleans | Louisiana |
| United States | Site 926 | Palm Springs | California |
| United States | Site 946 | Pasadena | California |
| United States | Site 957 | Pensacola | Florida |
| United States | Site 941 | Philadelphia | Pennsylvania |
| United States | Site 923 | Port St. Lucie | Florida |
| United States | Site 929 | Sarasota | Florida |
| United States | Site 956 | Somers Point | New Jersey |
| United States | Site 915 | Springfield | Missouri |
| United States | Site 909 | Tacoma | Washington |
| United States | Site 952 | Tallahassee | Florida |
| United States | Site 931 | Tampa | Florida |
| United States | Site 913 | Tarzana | California |
| United States | Site 927 | Vancouver | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm | 2 weeks | No | |
| Secondary | Number of episodes vomiting/retching | 2 weeks | No | |
| Secondary | Duration of nausea, vomiting/retching | 2 weeks | No | |
| Secondary | Intensity of nausea by VAS | 2 weeks | No | |
| Secondary | Appetite stimulation by VAS | 2 weeks | No |
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