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

Condition(s) targeted: Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting; HIV Infections

Intervention: Dronabinol (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

Number of episodes vomiting/retching

Duration of nausea, vomiting/retching

Intensity of nausea by VAS

Appetite stimulation by VAS

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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).

Site 911, Bakersfield, California, United States

Site 913, Tarzana, California, United States

Site 919, Fresno, California, United States

Site 924, Los Angeles, California, United States

Site 926, Palm Springs, California, United States

Site 932, Los Angeles, California, United States

Site 946, Pasadena, California, United States

Site 907, Altamonte Springs, Florida, United States

Site 923, Port St. Lucie, Florida, United States

Site 929, Sarasota, Florida, United States

Site 931, Tampa, Florida, United States

Site 948, Miami, Florida, United States

Site 951, Miami, Florida, United States

Site 952, Tallahassee, Florida, United States

Site 953, Miami, Florida, United States

Site 954, N. Palm Beach, Florida, United States

Site 957, Pensacola, Florida, United States

Site 959, Miami, 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

Site 915, Springfield, Missouri, United States

Site 956, Somers Point, New Jersey, United States

Site 921, Albany, New York, United States

Site 910, Cincinnati, Ohio, United States

Site 941, Philadelphia, Pennsylvania, United States

Site 906, Houston, Texas, United States

Site 917, Fort Worth, Texas, United States

Site 925, Dallas, Texas, United States

Site 942, Houston, Texas, United States

Site 909, Tacoma, Washington, United States

Site 927, Vancouver, Washington, United States

Starting date: August 2003
Ending date: April 2005
Last updated: April 1, 2008