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 914; 🇺🇸 Chicago, Illinois, United States

Site 929; 🇺🇸 Sarasota, Florida, United States

Site 952; 🇺🇸 Tallahassee, Florida, United States

Site 905; 🇺🇸 Boise, Idaho, United States

Site 921; 🇺🇸 Albany, New York, United States

Site 941; 🇺🇸 Philadelphia, Pennsylvania, United States

Site 948; 🇺🇸 Miami, Florida, United States

Site 951; 🇺🇸 Miami, Florida, United States

Site 959; 🇺🇸 Miami, Florida, United States

Site 919; 🇺🇸 Fresno, California, United States

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

Site 953; 🇺🇸 Miami, Florida, United States

Site 913; 🇺🇸 Tarzana, California, United States

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

Site 957; 🇺🇸 Pensacola, Florida, United States

Site 954; 🇺🇸 N. Palm Beach, Florida, United States

Site 931; 🇺🇸 Tampa, Florida, United States

Site 958; 🇺🇸 New Orleans, Louisiana, United States

Site 925; 🇺🇸 Dallas, Texas, United States

Site 927; 🇺🇸 Vancouver, Washington, United States

Site 915; 🇺🇸 Springfield, Missouri, United States

Site 910; 🇺🇸 Cincinnati, Ohio, United States

Site 909; 🇺🇸 Tacoma, Washington, United States

Site 906; 🇺🇸 Houston, Texas, United States

Site 942; 🇺🇸 Houston, Texas, United States

Site 917; 🇺🇸 Fort Worth, Texas, United States

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

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

Site 911; 🇺🇸 Bakersfield, California, United States

Site 923; 🇺🇸 Port St. Lucie, Florida, United States

Site 946; 🇺🇸 Pasadena, California, United States

Site 955; 🇺🇸 Louisville, Kentucky, United States

Site 928; 🇺🇸 Louisville, Kentucky, United States

Site 908; 🇺🇸 Decatur, Georgia, United States

Site 934; 🇺🇸 Boston, Massachusetts, United States

Site 956; 🇺🇸 Somers Point, New Jersey, United States