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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/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
Experimental: 1	Drug: Dronabinol 2.5 mg to 40 mg
Placebo Comparator: 2	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

Show 36 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Vickie Baranowski, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00642499 History of Changes
Other Study ID Numbers:	S175.2.101
Study First Received:	March 21, 2008
Last Updated:	April 1, 2008
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Nausea
Vomiting
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Signs and Symptoms, Digestive
Signs and Symptoms
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012