search
Back to results

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

Primary Purpose

Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dronabinol
Placebo
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting focused on measuring HIV, AIDS, nausea, vomiting, HAART, Treatment Experienced, HIV Infections

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Site 911
  • Site 919
  • Site 924
  • Site 932
  • Site 926
  • Site 946
  • Site 913
  • Site 907
  • Site 948
  • Site 951
  • Site 953
  • Site 959
  • Site 954
  • Site 957
  • Site 923
  • Site 929
  • Site 952
  • Site 931
  • Site 908
  • Site 905
  • Site 914
  • Site 928
  • Site 955
  • Site 958
  • Site 934
  • Site 915
  • Site 956
  • Site 921
  • Site 910
  • Site 941
  • Site 925
  • Site 917
  • Site 906
  • Site 942
  • Site 909
  • Site 927

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm

Secondary Outcome Measures

Number of episodes vomiting/retching
Duration of nausea, vomiting/retching
Intensity of nausea by VAS
Appetite stimulation by VAS

Full Information

First Posted
March 21, 2008
Last Updated
April 1, 2008
Sponsor
Solvay Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00642499
Brief Title
Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting
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 Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting, HIV Infections
Keywords
HIV, AIDS, nausea, vomiting, HAART, Treatment Experienced, HIV Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dronabinol
Intervention Description
2.5 mg to 40 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Number of episodes vomiting/retching
Time Frame
2 weeks
Title
Duration of nausea, vomiting/retching
Time Frame
2 weeks
Title
Intensity of nausea by VAS
Time Frame
2 weeks
Title
Appetite stimulation by VAS
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 911
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Site 919
City
Fresno
State/Province
California
Country
United States
Facility Name
Site 924
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 932
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 926
City
Palm Springs
State/Province
California
Country
United States
Facility Name
Site 946
City
Pasadena
State/Province
California
Country
United States
Facility Name
Site 913
City
Tarzana
State/Province
California
Country
United States
Facility Name
Site 907
City
Altamonte Springs
State/Province
Florida
Country
United States
Facility Name
Site 948
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 951
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 953
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 959
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 954
City
N. Palm Beach
State/Province
Florida
Country
United States
Facility Name
Site 957
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Site 923
City
Port St. Lucie
State/Province
Florida
Country
United States
Facility Name
Site 929
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Site 952
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Site 931
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site 908
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Site 905
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Site 914
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 928
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Site 955
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Site 958
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Site 934
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Site 915
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
Site 956
City
Somers Point
State/Province
New Jersey
Country
United States
Facility Name
Site 921
City
Albany
State/Province
New York
Country
United States
Facility Name
Site 910
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 941
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 925
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Site 917
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Site 906
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 942
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 909
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Site 927
City
Vancouver
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs