Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clavulanate potassium

Pseudoephedrine hydrochloride

Amoxicillin trihydrate

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring 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

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Immune Enhancement Project

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002149

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Immune Enhancement Project

1. Study Identification

Unique Protocol Identification Number

NCT00002149

Brief Title

Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

Official Title

Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 1997

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Immune Enhancement Project

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Sinusitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Clavulanate potassium

Intervention Type

Drug

Intervention Name(s)

Pseudoephedrine hydrochloride

Intervention Type

Drug

Intervention Name(s)

Amoxicillin trihydrate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Immune Enhancement Project

City

San Francisco

State/Province

California

ZIP/Postal Code

94114

Country

United States

HIV Infections, Sinusitis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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