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Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002149
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
HIV Infections Sinusitis Drug: Clavulanate potassium Drug: Pseudoephedrine hydrochloride Drug: Amoxicillin trihydrate Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiviral medication.

Patients must have:

  • HIV infection.
  • CD4 count >= 50 cells/mm3.
  • Recurrent sinusitis.
  • No active opportunistic infection.
  • No disease progression.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active infection with fever > 102 F.
  • Neurological symptoms such as epidural abscess, subdural hematoma, meningitis, and dementia.
  • Malignant neoplasm of nasal passages.
  • Not expected to remain clinically stable for the next 6 months.
  • Inability to comply with protocol requirements.
  • Malabsorption or inability to take oral medication.
  • Concurrent participation on another study where antibiotics will be used.

Concurrent Medication:

Excluded:

  • Antibiotics other than Septra.

Concurrent Treatment:

Excluded:

  • Chinese herbal medicine or acupuncture unless on that study arm.
  • Surgical intervention that has abated symptoms.

Patients with the following prior condition are excluded:

History of allergic reaction to the study antibiotics.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002149


Locations
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United States, California
Immune Enhancement Project
San Francisco, California, United States, 94114
Sponsors and Collaborators
Immune Enhancement Project
More Information
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ClinicalTrials.gov Identifier: NCT00002149    
Other Study ID Numbers: 243A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: September 1997
Keywords provided by NIH AIDS Clinical Trials Information Service:
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
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Pseudoephedrine
Ephedrine
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents