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

Phase 2

Completed

• Conditions: Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting; HIV Infections
• Interventions: Drug: Placebo; Drug: Dronabinol

• Registration Number: NCT00642499
• Lead Sponsor: Solvay Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Status Verified: 2008-03
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-25
• Last Update Submitted: 2008-04-01
• Last Update Posted: 2008-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Dronabinol	-

Primary Outcome Measures

Name	Time	Method
The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm	2 weeks

Secondary Outcome Measures

Name	Time	Method
Number of episodes vomiting/retching	2 weeks
Duration of nausea, vomiting/retching	2 weeks
Intensity of nausea by VAS	2 weeks
Appetite stimulation by VAS	2 weeks

Trial Locations

Locations (36)

Site 911; 🇺🇸 Bakersfield, California, United States

Site 919; 🇺🇸 Fresno, California, United States

Site 924; 🇺🇸 Los Angeles, California, United States

Site 932; 🇺🇸 Los Angeles, California, United States

Site 926; 🇺🇸 Palm Springs, California, United States

Site 946; 🇺🇸 Pasadena, California, United States

Site 913; 🇺🇸 Tarzana, California, United States

Site 907; 🇺🇸 Altamonte Springs, Florida, United States

Site 948; 🇺🇸 Miami, Florida, United States

Site 951; 🇺🇸 Miami, Florida, United States

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