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

Solvay

Status and phase: Completed; Phase 2

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

Treatments: Drug: Dronabinol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642499

S175.2.101

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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103 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Dronabinol

2

Placebo Comparator group

Treatment:

Drug: Placebo