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Home > "A" Clinical Trials Conditions > Acupuncture and Herbal Treatment of Chronic HIV Sinusitis  Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
For Condition: HIV Infections,Sinusitis
Status: Completed
Sponsor(s): Immune Enhancement Project ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 40
Location and Contact Information:
Immune Enhancement Project
San Francisco, California, 94114
United States
Additional Information:
Study ID Numbers: 243A;
Study Start Date:
Record last reviewed: September 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002149
Other Hiv Infections Studies:
1. A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
2. A Phase I Concentration-Controlled Trial to Assess the Safety, Tolerance, Pharmacokinetics and Development of Decreased HIV-1 Susceptibility to the Combination of Atevirdine Mesylate (U-87201E), Zidovudine (AZT), and Didanosine (ddI)
3. Safety and Effectiveness of Lamivudine When Given Once a Day versus Twice a Day in Combination with Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs
4. A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection
5. A Study of L-735,524 in HIV-Positive Children and Adolescents
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
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