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

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 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:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines Nausea and Vomiting

Drug Information available for: Dronabinol

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:


Acquired Immunodeficiency Syndrome HIV Infections Infection Nausea Vomiting Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Signs and Symptoms, Digestive Slow Virus Diseases	Virus Diseases Dronabinol Analgesics Analgesics, Non-Narcotic Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Central Nervous System Agents Hallucinogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 25, 2015