Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00642499
First Posted: March 25, 2008
Last Update Posted: April 2, 2008
Information provided by:
Solvay Pharmaceuticals
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting HIV Infections | Drug: Dronabinol Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Solvay Pharmaceuticals:
Primary Outcome Measures:
- The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm [ Time Frame: 2 weeks ]
Secondary Outcome Measures:
- Number of episodes vomiting/retching [ Time Frame: 2 weeks ]
- Duration of nausea, vomiting/retching [ Time Frame: 2 weeks ]
- Intensity of nausea by VAS [ Time Frame: 2 weeks ]
- Appetite stimulation by VAS [ Time Frame: 2 weeks ]
| Enrollment: | 103 |
| Study Start Date: | August 2003 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Dronabinol
2.5 mg to 40 mg
|
| Placebo Comparator: 2 |
Drug: Placebo
placebo
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642499
Show 36 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Responsible Party: | Vickie Baranowski, Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00642499 History of Changes |
| Other Study ID Numbers: |
S175.2.101 |
| First Submitted: | March 21, 2008 |
| First Posted: | March 25, 2008 |
| Last Update Posted: | April 2, 2008 |
| Last Verified: | March 2008 |
Keywords provided by Solvay Pharmaceuticals:
|
HIV AIDS nausea vomiting |
HAART Treatment Experienced HIV Infections |
Additional relevant MeSH terms:
|
HIV Infections Nausea Vomiting Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms Dronabinol |
Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |