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Sponsored by: |
Immune Enhancement Project |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002149 |
To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis. Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.
Condition | Intervention |
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HIV Infections Sinusitis |
Drug: Clavulanate potassium Drug: Pseudoephedrine hydrochloride Drug: Amoxicillin trihydrate |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Efficacy Study |
Official Title: | Acupuncture and Herbal Treatment of Chronic HIV Sinusitis |
Estimated Enrollment: | 40 |
Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.
Patients are randomized to receive either Traditional Chinese Medicine (acupuncture and herbal treatment) or conventional antibiotic therapy (Sudafed and Augmentin). Treatment continues for 8 weeks, followed by a 4 week washout, with final follow-up at week 12. Patients must undergo endoscopic nasal exam and CT scan of paranasal sinus prior to study entry and at week 12.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior condition are excluded:
History of allergic reaction to the study antibiotics.
Study ID Numbers: | 243A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002149 History of Changes |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Sinusitis Ephedrine |
Acupuncture Therapy Drugs, Chinese Herbal Medicine, Chinese Traditional Drug Combinations Antibiotics, Combined Amoxicillin-Potassium Clavulanate Combination |
Opportunistic Infections Anti-Infective Agents Neurotransmitter Agents Sexually Transmitted Diseases, Viral Adrenergic Agents Clavulanic Acids Sinusitis Nasal Decongestants Anti-Bacterial Agents Respiratory Tract Infections Respiratory Tract Diseases Phenylephrine Clavulanic Acid AIDS-Related Opportunistic Infections Vasoconstrictor Agents |
Retroviridae Infections Pseudoephedrine Amoxicillin Otorhinolaryngologic Diseases Acquired Immunodeficiency Syndrome Anti-Asthmatic Agents Central Nervous System Stimulants AIDS-Related Complex Cardiovascular Agents Amoxicillin-Potassium Clavulanate Combination Immunologic Deficiency Syndromes Virus Diseases Oxymetazoline HIV Infections Sexually Transmitted Diseases |
Respiratory System Agents Anti-Infective Agents Neurotransmitter Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Agents Paranasal Sinus Diseases Physiological Effects of Drugs Clavulanic Acids Sinusitis Infection Nasal Decongestants Anti-Bacterial Agents Respiratory Tract Diseases |
Respiratory Tract Infections Therapeutic Uses Clavulanic Acid Vasoconstrictor Agents Retroviridae Infections Pseudoephedrine RNA Virus Infections Amoxicillin Otorhinolaryngologic Diseases Immune System Diseases Sympathomimetics Acquired Immunodeficiency Syndrome Anti-Asthmatic Agents Enzyme Inhibitors Central Nervous System Stimulants |