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Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

This study has been completed.

Sponsored by: Immune Enhancement Project
Information provided by: AIDS Clinical Trials Information Service

Purpose

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 Treatment or Intervention
HIV Infections
Sinusitis
 Drug: Clavulanate potassium
 Drug: Pseudoephedrine hydrochloride
 Drug: Amoxicillin trihydrate

MedlinePlus related topics:  AIDS;   Sinusitis

Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Efficacy Study

Further Study Details: 

Expected Total 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.

Eligibility

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

Concurrent Medication: Excluded:


Location Information


California
      Immune Enhancement Project, San Francisco,  California,  94114,  United States

More Information

Study ID Numbers:  243A
Record last reviewed:  September 1997
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002149
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20
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