CompletedNCT00642499Updated Apr 2, 2008

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

A Phase 2 interventional study of Dronabinol and Placebo in Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting and HIV Infections, sponsored by Solvay Pharmaceuticals. Completed at 36 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-04-02.

Sponsored by Solvay Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 103
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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

Conditions studied

Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting
HIV Infections

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Keywords

HIV
AIDS
nausea
vomiting
HAART
Treatment Experienced
HIV Infections

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 103 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

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Lead sponsor

Solvay Pharmaceuticals is the lead sponsor of 84 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 103 participants (actual)

Study arms

Experimental
1
Drug: Dronabinol
Placebo comparator
2
Drug: Placebo

Interventions

DrugDronabinol
2.5 mg to 40 mg
DrugPlacebo
placebo

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

36 sites

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
N. Palm Beach, Florida, United States
Site 957
Pensacola, Florida, United States
Site 923
Port St. 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
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 925
Dallas, Texas, United States
Site 917
Fort Worth, Texas, United States
Site 906
Houston, Texas, United States
Site 942
Houston, Texas, United States
Site 909
Tacoma, Washington, United States
Site 927
Vancouver, Washington, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00642499
Lead sponsor: Solvay Pharmaceuticals
First posted: Mar 25, 2008
Start date: Aug 2003
Primary completion: Apr 2005
Completion: Apr 2005
Last update: Apr 2, 2008

Study contacts

Global Clinical Director Solvay

study director · Solvay Pharmaceuticals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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