Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00642499
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : April 2, 2008
Information provided by:
Solvay Pharmaceuticals

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

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

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Dronabinol
2.5 mg to 40 mg
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Number of episodes vomiting/retching [ Time Frame: 2 weeks ]
  2. Duration of nausea, vomiting/retching [ Time Frame: 2 weeks ]
  3. Intensity of nausea by VAS [ Time Frame: 2 weeks ]
  4. Appetite stimulation by VAS [ Time Frame: 2 weeks ]

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

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).

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 identifier (NCT number): NCT00642499

  Hide Study Locations
United States, California
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
United States, Florida
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
N. Palm Beach, Florida, United States
Site 957
Pensacola, Florida, United States
Site 923
Port St. Lucie, Florida, United States
Site 929
Sarasota, Florida, United States
Site 952
Tallahassee, Florida, United States
Site 931
Tampa, Florida, United States
United States, Georgia
Site 908
Decatur, Georgia, United States
United States, Idaho
Site 905
Boise, Idaho, United States
United States, Illinois
Site 914
Chicago, Illinois, United States
United States, Kentucky
Site 928
Louisville, Kentucky, United States
Site 955
Louisville, Kentucky, United States
United States, Louisiana
Site 958
New Orleans, Louisiana, United States
United States, Massachusetts
Site 934
Boston, Massachusetts, United States
United States, Missouri
Site 915
Springfield, Missouri, United States
United States, New Jersey
Site 956
Somers Point, New Jersey, United States
United States, New York
Site 921
Albany, New York, United States
United States, Ohio
Site 910
Cincinnati, Ohio, United States
United States, Pennsylvania
Site 941
Philadelphia, Pennsylvania, United States
United States, Texas
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
United States, Washington
Site 909
Tacoma, Washington, United States
Site 927
Vancouver, Washington, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Responsible Party: Vickie Baranowski, Solvay Pharmaceuticals 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:
Treatment Experienced
HIV Infections

Additional relevant MeSH terms:
HIV Infections
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
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists