Clinical trial NCT00642499: Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting
HIV Infections
Keywords: HIV
AIDS
nausea
vomiting
HAART
Treatment Experienced
HIV Infections
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of episodes vomiting/retching
timeFrame: 2 weeks
measure: Duration of nausea, vomiting/retching
timeFrame: 2 weeks
measure: Intensity of nausea by VAS
timeFrame: 2 weeks
measure: Appetite stimulation by VAS
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Site 911
state: California
city: Fresno
country: United States
facility: Site 919
state: California
city: Los Angeles
country: United States
facility: Site 924
state: California
city: Los Angeles
country: United States
facility: Site 932
state: California
city: Palm Springs
country: United States
facility: Site 926
state: California
city: Pasadena
country: United States
facility: Site 946
state: California
city: Tarzana
country: United States
facility: Site 913
state: California
city: Altamonte Springs
country: United States
facility: Site 907
state: Florida
city: Miami
country: United States
facility: Site 948
state: Florida
city: Miami
country: United States
facility: Site 951
state: Florida
city: Miami
country: United States
facility: Site 953
state: Florida
city: Miami
country: United States
facility: Site 959
state: Florida
city: N. Palm Beach
country: United States
facility: Site 954
state: Florida
city: Pensacola
country: United States
facility: Site 957
state: Florida
city: Port St. Lucie
country: United States
facility: Site 923
state: Florida
city: Sarasota
country: United States
facility: Site 929
state: Florida
city: Tallahassee
country: United States
facility: Site 952
state: Florida
city: Tampa
country: United States
facility: Site 931
state: Florida
city: Decatur
country: United States
facility: Site 908
state: Georgia
city: Boise
country: United States
facility: Site 905
state: Idaho
city: Chicago
country: United States
facility: Site 914
state: Illinois
city: Louisville
country: United States
facility: Site 928
state: Kentucky
city: Louisville
country: United States
facility: Site 955
state: Kentucky
city: New Orleans
country: United States
facility: Site 958
state: Louisiana
city: Boston
country: United States
facility: Site 934
state: Massachusetts
city: Springfield
country: United States
facility: Site 915
state: Missouri
city: Somers Point
country: United States
facility: Site 956
state: New Jersey
city: Albany
country: United States
facility: Site 921
state: New York
city: Cincinnati
country: United States
facility: Site 910
state: Ohio
city: Philadelphia
country: United States
facility: Site 941
state: Pennsylvania
city: Dallas
country: United States
facility: Site 925
state: Texas
city: Fort Worth
country: United States
facility: Site 917
state: Texas
city: Houston
country: United States
facility: Site 906
state: Texas
city: Houston
country: United States
facility: Site 942
state: Texas
city: Tacoma
country: United States
facility: Site 909
state: Washington
city: Vancouver
country: United States
facility: Site 927
state: Washington
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: