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Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Sinusitis

Intervention: Clavulanate potassium (Drug); Pseudoephedrine hydrochloride (Drug); Amoxicillin trihydrate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Immune Enhancement Project

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.

Clinical Details

Official title: Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

Study design: Treatment, Parallel Assignment, Efficacy Study

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

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


Last updated: June 23, 2005

Page last updated: June 20, 2008

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