PapillomaPhase 1NCT00001126
Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)
A Phase 1 study testing Cidofovir in people with Papilloma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to see what dose of the drug cidofovir is safe to treat laryngeal papillomatosis (warts in the throat which occur over and over) in children. Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus (HPV). Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Papilloma
- What is being tested?
- Cidofovir
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2005
- Phase
- Phase 1
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Your child may be eligible for this study if he/she:
- Has active laryngeal papillomatosis (warts in the throat) that requires 8 or more surgeries per year.
- Developed this infection before the age of 16.
- Is between the ages of 2 and 17 years with consent of parent or guardian.
Who cannot join
- Your child will not be eligible for this study if he/she:
- Has a history of a prior malignancy (cancer), kidney disease, or immune system deficiency.
- Is HIV-positive.
- Is allergic to probenecid.
- Has received radiation therapy to the throat area or has received certain medications.
- Is pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIAID/DMID/CASG Central Unit
Birmingham, Alabama, 35294
About this study
Official title: A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children
The purpose of this study is to see what dose of the drug cidofovir is safe to treat laryngeal papillomatosis (warts in the throat which occur over and over) in children.
Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus (HPV). At present, there is no approved drug to treat this infection. However, cidofovir is a drug effective against several viruses. Cidofovir may be able to attack the HPV virus. This study tests the safety of giving this drug to children.
Read the detailed description
Your child will be assigned randomly (like tossing a coin) to receive either cidofovir or placebo (an inactive substance). Neither you nor your doctor will know which your child is receiving. Your child will undergo a total of 6 bronchoscopic procedures, which involves placing a tube down your child's throat so that the warts can be seen and treated. The warts will be removed by laser or other procedures and the study drug injected. Study drug will be injected at the sites of all newly removed warts and warts which were removed during earlier study visits. This procedure will be performed every other week. Blood and urine tests will also be performed at this time. Your child will be under general anesthesia during each procedure and will be in the surgery unit for about 6 to 8 hours. Your child will also have to be seen by the doctor 2 days after the procedure. Your child will be followed for a total of 5 years to make sure he/she develops normally and to monitor any side effects of cidofovir. Follow-up visits will take place at Months 3, 6, and then once every 6 months through Year 5. If necessary, laser or other procedures will be performed at these visits to remove any warts.
- Conditions
- Papilloma
- Being tested
- Cidofovir
- Medical subject headings
- Papilloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CidofovirDrug
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)
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PapillomaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001126
- Sponsor's protocol ID
- DMID 97-023
- Status last verified
- Nov 2005
- First submitted
- 17 Jan 2000
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children
- ClinicalTrials.gov ID
- NCT00001126
- Acronym / sponsor ID
- DMID 97-023
- Conditions
- Papilloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Nov 2005
- 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.
The purpose of this study is to see what dose of the drug cidofovir is safe to treat laryngeal papillomatosis (warts in the throat which occur over and over) in children.
Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus (HPV). At present, there is no approved drug to treat this infection. However, cidofovir is a drug effective against several viruses. Cidofovir may be able to attack the HPV virus. This study tests the safety of giving this drug to children.
Detailed description
Your child will be assigned randomly (like tossing a coin) to receive either cidofovir or placebo (an inactive substance). Neither you nor your doctor will know which your child is receiving. Your child will undergo a total of 6 bronchoscopic procedures, which involves placing a tube down your child's throat so that the warts can be seen and treated. The warts will be removed by laser or other procedures and the study drug injected. Study drug will be injected at the sites of all newly removed warts and warts which were removed during earlier study visits. This procedure will be performed every other week. Blood and urine tests will also be performed at this time. Your child will be under general anesthesia during each procedure and will be in the surgery unit for about 6 to 8 hours. Your child will also have to be seen by the doctor 2 days after the procedure. Your child will be followed for a total of 5 years to make sure he/she develops normally and to monitor any side effects of cidofovir. Follow-up visits will take place at Months 3, 6, and then once every 6 months through Year 5. If necessary, laser or other procedures will be performed at these visits to remove any warts.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Has active laryngeal papillomatosis (warts in the throat) that requires 8 or more surgeries per year.
- Developed this infection before the age of 16.
- Is between the ages of 2 and 17 years with consent of parent or guardian.
Key exclusion criteria (6 listed)
- Has a history of a prior malignancy (cancer), kidney disease, or immune system deficiency.
- Is HIV-positive.
- Is allergic to probenecid.
- Has received radiation therapy to the throat area or has received certain medications.
- Is pregnant or breast-feeding.
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 |
|---|---|---|
| Cidofovir | 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 27 Aug 2010.
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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 Phase 1 study testing Cidofovir in people with Papilloma, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 4 inclusion and 6 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 27 Aug 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 27 Aug 2010.