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

April 1, 2008 updated by: Solvay Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States
        • Site 911
      • Fresno, California, United States
        • Site 919
      • Los Angeles, California, United States
        • Site 924
      • Los Angeles, California, United States
        • Site 932
      • Palm Springs, California, United States
        • Site 926
      • Pasadena, California, United States
        • Site 946
      • Tarzana, California, United States
        • Site 913
    • Florida
      • Altamonte Springs, Florida, United States
        • Site 907
      • Miami, Florida, United States
        • Site 948
      • Miami, Florida, United States
        • Site 951
      • Miami, Florida, United States
        • Site 953
      • Miami, Florida, United States
        • Site 959
      • N. Palm Beach, Florida, United States
        • Site 954
      • Pensacola, Florida, United States
        • Site 957
      • Port St. Lucie, Florida, United States
        • Site 923
      • Sarasota, Florida, United States
        • Site 929
      • Tallahassee, Florida, United States
        • Site 952
      • Tampa, Florida, United States
        • Site 931
    • Georgia
      • Decatur, Georgia, United States
        • Site 908
    • Idaho
      • Boise, Idaho, United States
        • Site 905
    • Illinois
      • Chicago, Illinois, United States
        • Site 914
    • Kentucky
      • Louisville, Kentucky, United States
        • Site 928
      • Louisville, Kentucky, United States
        • Site 955
    • Louisiana
      • New Orleans, Louisiana, United States
        • Site 958
    • Massachusetts
      • Boston, Massachusetts, United States
        • Site 934
    • Missouri
      • Springfield, Missouri, United States
        • Site 915
    • New Jersey
      • Somers Point, New Jersey, United States
        • Site 956
    • New York
      • Albany, New York, United States
        • Site 921
    • Ohio
      • Cincinnati, Ohio, United States
        • Site 910
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Site 941
    • Texas
      • Dallas, Texas, United States
        • Site 925
      • Fort Worth, Texas, United States
        • Site 917
      • Houston, Texas, United States
        • Site 906
      • Houston, Texas, United States
        • Site 942
    • Washington
      • Tacoma, Washington, United States
        • Site 909
      • Vancouver, Washington, United States
        • Site 927

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of episodes vomiting/retching
Time Frame: 2 weeks
2 weeks
Duration of nausea, vomiting/retching
Time Frame: 2 weeks
2 weeks
Intensity of nausea by VAS
Time Frame: 2 weeks
2 weeks
Appetite stimulation by VAS
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 2, 2008

Last Update Submitted That Met QC Criteria

April 1, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S175.2.101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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