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

NCT ID: NCT00642499

Last Updated: 2008-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-04-30

Brief Summary

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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

Detailed Description

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Conditions

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

Keywords

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HIV AIDS nausea vomiting HAART Treatment Experienced HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Dronabinol

Intervention Type DRUG

2.5 mg to 40 mg

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Dronabinol

2.5 mg to 40 mg

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Solvay Pharmaceuticals

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 911

Bakersfield, California, United States

Site Status

Site 919

Fresno, California, United States

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Site 924

Los Angeles, California, United States

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Site 932

Los Angeles, California, United States

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Site 926

Palm Springs, California, United States

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Site 946

Pasadena, California, United States

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Site 913

Tarzana, California, United States

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Site 907

Altamonte Springs, Florida, United States

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Site 948

Miami, Florida, United States

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Site 951

Miami, Florida, United States

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Site 953

Miami, Florida, United States

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Site 959

Miami, Florida, United States

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Site 954

North Palm Beach, Florida, United States

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Site 957

Pensacola, Florida, United States

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Site 923

Port Saint Lucie, Florida, United States

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Site 929

Sarasota, Florida, United States

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Site 952

Tallahassee, Florida, United States

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Site 931

Tampa, Florida, United States

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Site 908

Decatur, Georgia, United States

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Site 905

Boise, Idaho, United States

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Site 914

Chicago, Illinois, United States

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Site 928

Louisville, Kentucky, United States

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Site 955

Louisville, Kentucky, United States

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Site 958

New Orleans, Louisiana, United States

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Site 934

Boston, Massachusetts, United States

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Site 915

Springfield, Missouri, United States

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Site 956

Somers Point, New Jersey, United States

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Site 921

Albany, New York, United States

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Site 910

Cincinnati, Ohio, United States

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Site 941

Philadelphia, Pennsylvania, United States

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Site 925

Dallas, Texas, United States

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Site 917

Fort Worth, Texas, United States

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Site 906

Houston, Texas, United States

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Site 942

Houston, Texas, United States

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Site 909

Tacoma, Washington, United States

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Site 927

Vancouver, Washington, United States

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Countries

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United States

Other Identifiers

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S175.2.101

Identifier Type: -

Identifier Source: org_study_id