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Sponsored by: |
Solvay Pharmaceuticals |
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Information provided by: | Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00642499 |
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
Condition | Intervention | Phase |
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Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting HIV Infections |
Drug: Dronabinol Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Enrollment: | 103 |
Study Start Date: | August 2003 |
Study Completion Date: | April 2005 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Dronabinol
2.5 mg to 40 mg
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2: Placebo Comparator |
Drug: Placebo
placebo
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Solvay Pharmaceuticals ( Vickie Baranowski ) |
Study ID Numbers: | S175.2.101 |
Study First Received: | March 21, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00642499 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV AIDS nausea vomiting |
HAART Treatment Experienced HIV Infections |
Sexually Transmitted Diseases, Viral Vomiting Signs and Symptoms, Digestive Acquired Immunodeficiency Syndrome Psychotropic Drugs Immunologic Deficiency Syndromes Virus Diseases Tetrahydrocannabinol |
Signs and Symptoms Analgesics, Non-Narcotic HIV Infections Sexually Transmitted Diseases Nausea Peripheral Nervous System Agents Analgesics Retroviridae Infections |
Sexually Transmitted Diseases, Viral Vomiting Slow Virus Diseases Signs and Symptoms, Digestive Physiological Effects of Drugs Psychotropic Drugs Hallucinogens Infection Signs and Symptoms Sensory System Agents Therapeutic Uses Nausea Analgesics Retroviridae Infections |
RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Tetrahydrocannabinol HIV Infections Analgesics, Non-Narcotic Sexually Transmitted Diseases Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents |