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

Completed · Phase 2 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT00642499

Run by

Solvay Pharmaceuticals

People needed

103

Starts

2003-08-01

Expected to finish

2005-04-01

Last updated by the study team

2008-04-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• 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
• Site 953 — Miami, Florida, United States
• Site 959 — Miami, Florida, United States
• Site 954 — North Palm Beach, Florida, United States
• Site 957 — Pensacola, Florida, United States
• Site 923 — Port Saint Lucie, Florida, United States
• Site 929 — Sarasota, Florida, United States
• Site 952 — Tallahassee, Florida, United States
• Site 931 — Tampa, Florida, United States
• Site 908 — Decatur, Georgia, United States
• Site 905 — Boise, Idaho, United States
• Site 914 — Chicago, Illinois, United States
• Site 928 — Louisville, Kentucky, United States
• Site 955 — Louisville, Kentucky, United States
• Site 958 — New Orleans, Louisiana, United States
• Site 934 — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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