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Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002149
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: September 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002149 on ClinicalTrials.gov Archive Site
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Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

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.

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.

Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • HIV Infections
  • Sinusitis
  • Drug: Clavulanate potassium
  • Drug: Pseudoephedrine hydrochloride
  • Drug: Amoxicillin trihydrate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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.

Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002149
243A
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Immune Enhancement Project
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NIH AIDS Clinical Trials Information Service
September 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP