NCT00642499CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Solvay Pharmaceuticals
- Enrollment
- 103
- Locations
- 36
- Primary Endpoint
- The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
1
Experimental
Intervention: Dronabinol (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
Time Frame: 2 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (36)
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