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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00642499

Enrollment

103

Registered

2008-03-25

Start date

2003-08-31

Completion date

2005-04-30

Last updated

2008-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HIV, AIDS, nausea, vomiting, HAART, Treatment Experienced, HIV Infections

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

Interventions

DRUGDronabinol

2.5 mg to 40 mg

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026