Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
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| ClinicalTrials.gov Identifier: NCT00002149 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Sinusitis | Drug: Clavulanate potassium Drug: Pseudoephedrine hydrochloride Drug: Amoxicillin trihydrate | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 40 participants |
| Intervention Model: | Parallel Assignment |
| Primary Purpose: | Treatment |
| Official Title: | Acupuncture and Herbal Treatment of Chronic HIV Sinusitis |
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002149
| United States, California | |
| Immune Enhancement Project | |
| San Francisco, California, United States, 94114 | |
| ClinicalTrials.gov Identifier: | NCT00002149 History of Changes |
| Other Study ID Numbers: |
243A |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | September 1997 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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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 |
Additional relevant MeSH terms:
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HIV Infections Sinusitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
Amoxicillin Clavulanic Acid Clavulanic Acids Amoxicillin-Potassium Clavulanate Combination Pseudoephedrine Ephedrine Anti-Bacterial Agents Anti-Infective Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Nasal Decongestants |