Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting
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ClinicalTrials.gov Identifier: NCT00642499 |
Recruitment Status
:
Completed
First Posted
: March 25, 2008
Last Update Posted
: April 2, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting HIV Infections | Drug: Dronabinol Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 103 participants |
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 |
Study Start Date : | August 2003 |
Actual Primary Completion Date : | April 2005 |
Actual Study Completion Date : | April 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Dronabinol
2.5 mg to 40 mg
|
Placebo Comparator: 2 |
Drug: Placebo
placebo
|
- The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm [ Time Frame: 2 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | 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).

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

Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Vickie Baranowski, Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00642499 History of Changes |
Other Study ID Numbers: |
S175.2.101 |
First Posted: | March 25, 2008 Key Record Dates |
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 |