Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

HIV Infections Clinical Trial

Official title:

Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002149
• Other study ID #: 243A
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: September 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Sinusitis

Intervention

Drug:
• Clavulanate potassium

• Pseudoephedrine hydrochloride

• Amoxicillin trihydrate

Locations

Country	Name	City	State
United States	Immune Enhancement Project	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Immune Enhancement Project

Country where clinical trial is conducted

United States,