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

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00642499

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: AIDS AIDS Medicines Nausea and Vomiting

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of episodes vomiting/retching [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Duration of nausea, vomiting/retching [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Intensity of nausea by VAS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Appetite stimulation by VAS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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
1: Experimental	Drug: Dronabinol 2.5 mg to 40 mg
2: Placebo Comparator	Drug: Placebo placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642499

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Locations

United States, California
Site 911
Bakersfield, California, United States
Site 913
Tarzana, California, United States
Site 919
Fresno, California, United States
Site 946
Pasadena, California, United States
Site 926
Palm Springs, California, United States
Site 932
Los Angeles, California, United States
Site 924
Los Angeles, California, United States
United States, Florida
Site 907
Altamonte Springs, Florida, United States
Site 923
Port St. Lucie, Florida, United States
Site 959
Miami, Florida, United States
Site 931
Tampa, Florida, United States
Site 948
Miami, Florida, United States
Site 951
Miami, Florida, United States
Site 952
Tallahassee, Florida, United States
Site 953
Miami, Florida, United States
Site 954
N. Palm Beach, Florida, United States
Site 957
Pensacola, Florida, United States
Site 929
Sarasota, 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 906
Houston, Texas, United States
Site 917
Fort Worth, Texas, United States
Site 925
Dallas, 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

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Vickie Baranowski )
Study ID Numbers:	S175.2.101
Study First Received:	March 21, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00642499 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

HIV
AIDS
nausea
vomiting

HAART
Treatment Experienced
HIV Infections

Additional relevant MeSH terms:

Communicable Diseases
Sexually Transmitted Diseases, Viral
Vomiting
Slow Virus Diseases
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Psychotropic Drugs
Hallucinogens
Infection
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Nausea
Analgesics

Retroviridae Infections
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Tetrahydrocannabinol
HIV Infections
Analgesics, Non-Narcotic
Sexually Transmitted Diseases
Lentivirus Infections
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009