HIV InfectionsNCT00002149
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
A study testing Clavulanate potassium, Pseudoephedrine hydrochloride and Amoxicillin trihydrate in people with HIV Infections and Sinusitis, run by Immune Enhancement Project at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections, Sinusitis
- What is being tested?
- Clavulanate potassium, Pseudoephedrine hydrochloride and Amoxicillin trihydrate
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiviral medication.
- Patients must have:
- HIV infection.
- CD4 count >= 50 cells/mm3.
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- Recurrent sinusitis.
- No active opportunistic infection.
- No disease progression.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Immune Enhancement Project
San Francisco, California, 94114
About this study
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.
Read the 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.
- Conditions
- HIV Infections, Sinusitis
- Being tested
- Clavulanate potassium, Pseudoephedrine hydrochloride, Amoxicillin trihydrate
- 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
- Medical subject headings
- HIV Infections, Sinusitis, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clavulanate potassiumDrug
Pseudoephedrine hydrochlorideDrug
Amoxicillin trihydrateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Immune Enhancement Project
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002149
- Sponsor's protocol ID
- 243A
- Status last verified
- Sep 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
- ClinicalTrials.gov ID
- NCT00002149
- Acronym / sponsor ID
- 243A
- Conditions
- HIV Infections, Sinusitis
- Keywords
- AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Sinusitis, Ephedrine, Acupuncture Therapy, Drugs, Chinese Herbal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Immune Enhancement ProjectUniversity, hospital or other
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Antiviral medication.
- HIV infection.
- CD4 count >= 50 cells/mm3.
- Recurrent sinusitis.
- No active opportunistic infection.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clavulanate potassium | Drug | – |
| Pseudoephedrine hydrochloride | Drug | – |
| Amoxicillin trihydrate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clavulanate potassium, Pseudoephedrine hydrochloride and Amoxicillin trihydrate in people with HIV Infections and Sinusitis, run by Immune Enhancement Project at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.