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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
Sponsor:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00642499


  Show 36 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
More Information

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