Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting
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
1 other identifier
interventional
103
1 country
36
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2003
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedApril 2, 2008
March 1, 2008
1.7 years
March 21, 2008
April 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
2 weeks
Secondary Outcomes (4)
Number of episodes vomiting/retching
2 weeks
Duration of nausea, vomiting/retching
2 weeks
Intensity of nausea by VAS
2 weeks
Appetite stimulation by VAS
2 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Site 911
Bakersfield, California, United States
Site 919
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 25, 2008
Study Start
August 1, 2003
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
April 2, 2008
Record last verified: 2008-03