Lymphatic FilariasisPhase 2NCT00511004
Effect of Albendazole Dose on Treatment of Lymphatic Filariasis
A Phase 2 study testing Albendazole and Diethylcarbamazine in people with Lymphatic Filariasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.
Trial summary
This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lymphatic Filariasis
- What is being tested?
- Albendazole and Diethylcarbamazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2007to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 years to 55 years inclusive
- Both genders
- Not pregnant or breastfeeding by history
- If selected, subjects must be willing to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India
- If selected, subjects must be willing to undergo nighttime blood draws once every 6 months and Doppler ultrasound twice yearly for 2 years
- If selected, agree to have blood stored for future studies
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- Ability to understand and give informed consent
- Age 18 to 55 years inclusive
- Men and non-pregnant or non-breast feeding women
- Microfilarial levels greater than 50mf/mL
- Willingness to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India every 6 months for 2 years
- Willingness to undergo nighttime blood draws once every 6 months for 2 years
- Ability to understand and give informed consent
- Hemaglobin (Hgb) levels for inclusion greater than 9 g/dL
- Creatinine (Cr) less than or equal to 1.2 mg/dL
- Alanine aminotransferase (ALT) less than 30 U/L
- Willingness to have blood stored for future studies
Who cannot join
- Age less than 18 years or greater than 55 years
- Pregnant or breast feeding by history
- Non-volunteers
- Age less than 18 years or greater than 55 years
- Pregnant or breast feeding
- Hgb levels less than or equal to 9 g/dL
Show all 15Show fewer
- Cr greater than 1.3 mg/dL
- ALT greater than 30 U/L
- Alcohol consumption of more than 2 beers or other alcohol-containing drinks/day within a week of each drug administration
- Temperature greater than 37.5 degrees Celsius
- Serious medical illness
- History of benzimidazole allergy
- History of DEC allergy
- Use of albendazole or DEC within past 6 months
- Unwillingness to comply with required study visits
Trial locations and contacts
1 site in 1 country.
India1 site
Filariasis Chemotherapy Unit (FCU), T.D. Medical Hospital
Alleppey, Kerala
About this study
Official title: Effect of Albendazole Dose and Interval on Brugia Malayi Microfilarial Clearance in India: A Randomized, Open Label Study
This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small parasitic worms that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or arms called elephantiasis. The study will see if a higher and more frequent dose of albendazole is better at clearing filarial worms from the blood than the current treatment.
Healthy people between 18 and 55 years of age who are in good health and who are infected with filarial worms may be eligible for this study.
Read more
Participants undergo the following procedures:
3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India
- Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years.
- Urine pregnancy test for women of childbearing age .
- Ultrasound test to look for filarial worms.
- Treatment dose.
- Monitoring for symptoms 6-month 3-day hospital stay
- Medical history, physical examination and blood test.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
- Treatment dose for subjects receiving medicine every 6 months.
- Urine pregnancy test for women of childbearing age. 1-year 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
- Urine pregnancy test for women of childbearing age. 18-month 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose for subjects receiving medicine every 6 months.
- Urine pregnancy test for women of childbearing age. 24-month 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
- Urine pregnancy test for women of childbearing age.
Read the detailed description
Albendazole and diethylcarbamazine (DEC) are currently used in combination for annual mass treatment of lymphatic filariasis in all parts of the world except Africa. Although the drugs have been donated, the cost of such programs is very high and has proven to be a major impediment to the success of programs in many countries with limited financial resources. Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose DEC/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. In this study, 75 volunteers with microfilaremic Brugia malayi infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg), annual therapy with increased dosing of albendazole (albendazole 800 mg + DEC 300 mg), or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). Microfilarial levels will be followed every 6 months for 2 years to determine whether the higher dose, and/or the more frequent regimen, is more effective.
- Conditions
- Lymphatic Filariasis
- Being tested
- Albendazole, Diethylcarbamazine
- Keywords
- Brugia Malayi, Lymphatic Filariasis, Albendazole, Diethylcarbamazine
- Medical subject headings
- Elephantiasis, Filarial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Also called Zentel
Comparing 400 mg to 800 mg dose
DiethylcarbamazineDrug
Also called Banocide
Providing diethylcarbamazine more frequently in combination with albendazole
| Study group | Role | What they receive |
|---|---|---|
| Diethylcarbamazine/Albendazole -STD | Active comparator | Standard therapy of DEC (300mg) and albendazole (400mg) yearly Receives: Drug: Albendazole; Drug: Diethylcarbamazine |
| Diethylcarbamazine/Albendazole- HD1 | Active comparator | High dose of DEC (300mg) and albendazole (800mg) yearly Receives: Drug: Albendazole; Drug: Diethylcarbamazine |
| Diethylcarbamazine/Albendazole-HD2 | Active comparator | High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months) Receives: Drug: Albendazole; Drug: Diethylcarbamazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microfilarial Counts at 1 Year
Night time microfilarial counts at 1 year
Measured: 1 year from time enrolled
Secondary outcomes (3)
Adult Worm Burdens at 2 Years
Doppler detected worm nests at 2 years
Measured: 2 years from the time enrolled.
Microfilarial Levels at 2 Years
Night time microfilarial levels at 2 years
Measured: 2 years from time enrolled
Brugia Specific Immunoglobulin G4 (IgG4) Antibodies
IgG4 antibodies directed against Brugia malayi antigen
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lymphatic FilariasisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas B Nutman, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511004
- Sponsor's protocol ID
- 999907197
- Other IDs
- 07-I-N197
- Status last verified
- Jul 2015
- First submitted
- 2 Aug 2007
- Last updated
- 31 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Edwards G, Awadzi K, Breckenridge AM, Gilles HM, Orme ML, Ward SA. Diethylcarbamazine disposition in patients with onchocerciasis. Clin Pharmacol Ther. 1981 Oct;30(4):551-7. doi: 10.1038/clpt.1981.202.
PubMed 7285488Taylor HR, Greene BM. Ocular changes with oral and transepidermal diethylcarbamazine therapy of onchocerciasis. Br J Ophthalmol. 1981 Jul;65(7):494-502. doi: 10.1136/bjo.65.7.494.
PubMed 7020746Partono F, Purnomo, Oemijati S, Soewarta A. The long term effects of repeated diethylcarbamazine administration with special reference to microfilaraemia and elephantiasis. Acta Trop. 1981 Sep;38(3):217-25.
PubMed 6118029
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Albendazole Dose and Interval on Brugia Malayi Microfilarial Clearance in India: A Randomized, Open Label Study
- ClinicalTrials.gov ID
- NCT00511004
- Acronym / sponsor ID
- 999907197
- Conditions
- Lymphatic Filariasis
- Keywords
- Brugia Malayi, Lymphatic Filariasis, Albendazole, Diethylcarbamazine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jul 2007
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Posted 31 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted in Kerala, India. It will determine whether a new treatment regimen of albendazole and diethylcarbamazine (DEC) for lymphatic filariasis can eliminate the disease more quickly than the standard regimen. Lymphatic filariasis is caused by infection with very small parasitic worms that are spread by mosquitoes. The disease can cause swelling of the arms, legs, breast and scrotum and can progress to permanent swelling of the legs or arms called elephantiasis. The study will see if a higher and more frequent dose of albendazole is better at clearing filarial worms from the blood than the current treatment.
Healthy people between 18 and 55 years of age who are in good health and who are infected with filarial worms may be eligible for this study.
Participants undergo the following procedures:
3-day hospital stay at the Filariasis Chemotherapy Unit of the T.D. Medical College Hospital in Kerala, India
- Random assignment to receive either: 400 mg albendazole and DEC 300 mg given once a year for 2 years (standard treatment); or 800 mg albendazole and DEC 300 mg given once a year for 2 years; or 800 mg albendazole and DEC 300 mg given twice a year for 2 years.
- Urine pregnancy test for women of childbearing age .
- Ultrasound test to look for filarial worms.
- Treatment dose.
- Monitoring for symptoms 6-month 3-day hospital stay
- Medical history, physical examination and blood test.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
- Treatment dose for subjects receiving medicine every 6 months.
- Urine pregnancy test for women of childbearing age. 1-year 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
- Urine pregnancy test for women of childbearing age. 18-month 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose for subjects receiving medicine every 6 months.
- Urine pregnancy test for women of childbearing age. 24-month 3-day hospital stay
- Medical history, physical examination and blood test.
- Treatment dose.
- Repeat ultrasound in subjects whose first ultrasound detected adult worms.
- Urine pregnancy test for women of childbearing age.
Detailed description
Albendazole and diethylcarbamazine (DEC) are currently used in combination for annual mass treatment of lymphatic filariasis in all parts of the world except Africa. Although the drugs have been donated, the cost of such programs is very high and has proven to be a major impediment to the success of programs in many countries with limited financial resources. Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose DEC/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. In this study, 75 volunteers with microfilaremic Brugia malayi infection will be randomized to receive standard annual therapy (albendazole 400 mg + DEC 300 mg), annual therapy with increased dosing of albendazole (albendazole 800 mg + DEC 300 mg), or semiannual therapy with an increased albendazole dose (albendazole 800 mg + DEC 300 mg). Microfilarial levels will be followed every 6 months for 2 years to determine whether the higher dose, and/or the more frequent regimen, is more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diethylcarbamazine/Albendazole -STD | Active comparator | Drug: Albendazole, Drug: DiethylcarbamazineStandard therapy of DEC (300mg) and albendazole (400mg) yearly |
| Diethylcarbamazine/Albendazole- HD1 | Active comparator | Drug: Albendazole, Drug: DiethylcarbamazineHigh dose of DEC (300mg) and albendazole (800mg) yearly |
| Diethylcarbamazine/Albendazole-HD2 | Active comparator | Drug: Albendazole, Drug: DiethylcarbamazineHigh dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age 18 years to 55 years inclusive
- Both genders
- Not pregnant or breastfeeding by history
- If selected, subjects must be willing to spend 3 days on the Filariasis Chemotherapy Unit at the T.D. Medical College Hospital, Alleppey, Kerala, India
- If selected, subjects must be willing to undergo nighttime blood draws once every 6 months and Doppler ultrasound twice yearly for 2 years
Key exclusion criteria (15 listed)
- Age less than 18 years or greater than 55 years
- Pregnant or breast feeding by history
- Non-volunteers
- Age less than 18 years or greater than 55 years
- 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 |
|---|---|---|
| AlbendazoleAlso: ZentelComparing 400 mg to 800 mg dose | Drug | Diethylcarbamazine/Albendazole -STD, Diethylcarbamazine/Albendazole- HD1, Diethylcarbamazine/Albendazole-HD2 |
| DiethylcarbamazineAlso: BanocideProviding diethylcarbamazine more frequently in combination with albendazole | Drug | Diethylcarbamazine/Albendazole -STD, Diethylcarbamazine/Albendazole- HD1, Diethylcarbamazine/Albendazole-HD2 |
Primary outcome
Microfilarial Counts at 1 Year
Time frame: 1 year from time enrolled
Night time microfilarial counts at 1 year
3 secondary outcomes
Adult Worm Burdens at 2 Years
Time frame: 2 years from the time enrolled.
Microfilarial Levels at 2 Years
Time frame: 2 years from time enrolled
Brugia Specific Immunoglobulin G4 (IgG4) Antibodies
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7285488Edwards G, Awadzi K, Breckenridge AM, Gilles HM, Orme ML, Ward SA. Diethylcarbamazine disposition in patients with onchocerciasis. Clin Pharmacol Ther. 1981 Oct;30(4):551-7. doi: 10.1038/clpt.1981.202.
- Background: PubMed 7020746Taylor HR, Greene BM. Ocular changes with oral and transepidermal diethylcarbamazine therapy of onchocerciasis. Br J Ophthalmol. 1981 Jul;65(7):494-502. doi: 10.1136/bjo.65.7.494.
- Background: PubMed 6118029Partono F, Purnomo, Oemijati S, Soewarta A. The long term effects of repeated diethylcarbamazine administration with special reference to microfilaraemia and elephantiasis. Acta Trop. 1981 Sep;38(3):217-25.
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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.
Thomas B Nutman, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albendazole and Diethylcarbamazine in people with Lymphatic Filariasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.
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 17 inclusion and 15 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 31 Aug 2015. 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 India. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Microfilarial Counts at 1 Year (time frame: 1 year from time enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00511004, which also lists 3 linked publications.
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 31 Aug 2015.