Guaifenesin, Hydrocodone, and Pseudoephedrine |
Duratuss HD; Hydro-Tussin HD; Hydro-Tussin XP; Pancof-XP; Su-Tuss HD; Tussend; ZTuss |
Clinical Trial: Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
This study has been completed.
|
Purpose
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 | Treatment or Intervention |
|---|---|
| HIV Infections Sinusitis | Drug: Clavulanate potassium Drug: Pseudoephedrine hydrochloride Drug: Amoxicillin trihydrate |
MedlinePlus related topics: AIDS; Sinusitis
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 40
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
Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: 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.
Location Information
California
Immune Enhancement Project, San Francisco, California, 94114, United States
More Information
Record last reviewed: September 1997
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002149
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Duratuss HD (Drug Digest)
- Guaifenesin, Hydrocodone, and Pseudoephedrine (Drug Digest)

Not Signed In -


