Status:
COMPLETED
Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00642499
Start Date
August 1 2003
End Date
April 1 2005
Last Update
April 2 2008
Active Locations (36)
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1
Site 911
Bakersfield, California, United States
2
Site 919
Fresno, California, United States
3
Site 924
Los Angeles, California, United States
4
Site 932
Los Angeles, California, United States