OnchocerciasisPhase 2DOLF IDA/OnchoNCT04188301

Safety and Efficacy of IDA for Onchocerciasis

A Phase 2 study testing IVM w/ ALB, Single dose of IDA and Three daily doses of IDA in people with Onchocerciasis, run by Washington University School of Medicine at 1 site in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This DOLF study will investigate the safety and effectiveness of IDA treatment in persons with onchocerciasis when it is administered after pre-treatment with ivermectin to clear or greatly reduce microfilariae from the skin and eyes. Read more about this study

Who is it for?: Ages 16 to 70 years
Conditions the study is for: Onchocerciasis
What is being tested?: IVM w/ ALB, Single dose of IDA and Three daily doses of IDA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 1 siteGhana
Study dates: 6 Dec 2019to 1 Jun 2022
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 16 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Men and women who were previously enrolled in the preceding Part I study (Protocol ID#201804116) and residing in the study area
Must have at least palpable subcutaneous nodule (onchocercoma)
Participants with baseline skin Mf counts less than or equal to 3 Mf/mg at the time of enrollment into the Part I study (Protocol ID#201804116)

Who cannot join

Pregnant and breastfeeding mothers within 1 month of giving birth
Severe eye disease at baseline including uveitis, severe glaucoma, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye as well as the list of ocular diseases as outlined below. All ocular disease exclusion criteria apply to either eye. Bilateral disease is not necessary to exclude a participant. A participant will be excluded if any of the criteria are met for one eye.
Any cataract of any type preventing clear visualization of fundus or imaging on Optical Coherence Tomography (OCT).
Severe retinal nerve fiber layer thinning in the superior and inferior quadrant analysis on Ocular Coherence Tomography of the optic nerve with a corresponding visual field defect of grade 2 or worse on the same eye.If Ocular Coherence Tomography is not available, the following exclusion criteria will apply: vertical Cup/disc ratio on fundoscopy (not by OCT reading) greater than or equal to 0.80.
Intraocular pressure (IOP) greater than or equal to 25 by Goldmann tonometry .12
Retinal Detachment or Retinal Break

Show all 27Show fewer

Acute ocular infection (i.e., Viral conjunctivitis, corneal ulcer, endophthalmitis)
Optic Atrophy with visual field defect reproducible on confrontation visual field testing..
Exam consistent with Herpes Simplex Virus eye infection
Homonymous hemianopsia, quadrantanopsia, bitemporal hemianopsia, or central scotoma related to cerebral vascular disease by Automated Visual Field testing and confrontation visual field testing.
Acute Angle Closure Glaucoma
Gonioscopy grade 0 (slit) limiting ability to safely dilate patient
Severe Tremor, blepharospasm, or other voluntary or involuntary motor condition that prevents ability to examine patient with slit lamp, OCT, gonioscopy, IOP measurement, fundus photography, and Frequency doubling technology perimetry.
Cognitive impairment sufficient to prevent ability to understand and perform Visual Acuity Test with Tumbling E chart, confrontation visual field, slit lamp exam, or any other ocular exam component.
Optic nerve edema
Active retinopathy or retinitis not attributable to onchocercal disease
History of uveitis not associated with onchocercal disease
Any pre-existing chorioretinal scar or retinal degeneration and other significant retinal pathologies (foveomacular schisis, dystrophies, arterial macroaneurysms etc) involving the macula.
Severe ocular pain, that patient rates as 9 or 10 out of 10 pain.
Best corrected or pinhole visual acuity worse than 6/60 (20/200)
Age related macular degeneration (AMD)
Significant comorbidities such as renal insufficiency, liver failure, or any other acute or chronic illness identified by study clinicians and investigators that interferes with the participant's ability to go to school or work or perform routine household chores.
Prior allergic / hypersensitivity reactions or intolerance to IVM, ALB, or DEC.
Treatment with IVM outside of the study after the pre-treatment clearing dose provided in the Part I study.
>5 motile Mf in the anterior chamber in either eye at the time of enrollment (after pre-treatment with IVM).
Any Mf identified in the posterior segment of the eye at the time of enrollment (six months after pre-treatment with IVM).
Any other condition identified by study clinicians or investigators that may preclude participation in the study.

Trial locations and contacts

1 site in 1 country.

Ghana1 site

University of Health and Allied Sciences
Hohoe

Other trials in Ghana

About this study

Official title: Safety and Efficacy of Combination Therapy With Ivermectin, Diethylcarbamazine, and Albendazole (IDA) for Individuals With Onchocerciasis

Read the detailed description

This study will provide preliminary data on the safety of IDA treatment in persons with onchocerciasis when it is administered after pre-treatment with IVM to clear or greatly reduce microfilariae from the skin and eyes. Widespread use of IDA following IVM pretreatment (I/IDA) has the potential to greatly accelerate elimination of lymphatic filariasis (LF) in African countries that are co-endemic for LF and onchocerciasis. study later.

This study will also assess the efficacy of IDA for killing and sterilizing adult filarial worms. An improved macrofilaricidal treatment would be a major advance for the global program to eliminate onchocerciasis. Since the safety and efficacy objectives are both very important, we have included dual primary objectives for the study.

Primary objectives:

Safety: To compare rates and types of severe adverse events (grade 3 or higher) that occur within 7 days following 1 day or 3 days of treatment with triple drug treatment ("IDA" = diethylcarbamazine (DEC) with ivermectin (IVM) and albendazole (ALB)) with the comparator regimen of 1 day of treatment with ivermectin and albendazole (IA) in persons with active Onchocerca volvulus infections after pretreatment with ivermectin alone.
Efficacy: To compare the effect of three treatment regimens (1 day of IDA, 3 days of IDA, or IA) for killing or sterilizing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment.

This is an open label, randomized clinical trial.

Conditions: Onchocerciasis
Being tested: IVM w/ ALB, Single dose of IDA, Three daily doses of IDA
Keywords: ophthalmology
Medical subject headings: Onchocerciasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IVM w/ ALBDrug
Also called IA
Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)
Single dose of IDADrug
Also called IVM/DEC/ALB (x1)
Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
Three daily doses of IDADrug
Also called IVM/DEC/ALB (x3)
Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Study groups in NCT04188301
Study group	Role	What they receive
IVM + ALB	Active comparator	Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) Receives: Drug: IVM w/ ALB
IDA x 1 dose	Experimental	Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) Receives: Drug: Single dose of IDA
IDA x 3 doses	Experimental	Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) Receives: Drug: Three daily doses of IDA

What is being measured

The primary outcome is the main question the study is designed to answer.

Rates of Severe Adverse Events (SAEs) Across Study Arms
Rates of severe adverse events (grade 3 or higher) following 1-day or 3-day triple drug treatment will be compared against those of the comparator regimen of 1 day of IVM/ALB.
Measured: Within 7 days following end of treatment
Percentage of Worms Killed Across Study Arms
The effect of three treatment regimens for killing adult female O. volvulus worms will be compared based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment.
Measured: 18 months following treatment.
Percentage of Worms Sterilized Across Study Arms
The effect of three treatment regimens for sterilizing adult female O. volvulus worms will be compared based on the percentage of all adult female worms that are fertile in the nodules 18 months after treatment.
Measured: 18 months following treatment.

Secondary outcomes (5)

Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA
Rates of adverse events grade 3 or higher that occur within 7 days of treatment in the subset of participants who have intraocular microfilariae just prior to treatment with IDA will be compared by treatment group.
Measured: within 7 days following end of treatment
Rates of Ocular Adverse Events (Any Grade) by Treatment Group
Rates of ocular adverse events of any grade within 3 months will be compared by treatment group.
Measured: within 3 months of treatment with IDA
Effectiveness of Killing Adult Female Worms
The effectiveness of three treatment regimens for killing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive 18 months after treatment.
Measured: 18 months following treatment
Effectiveness of Clearing Microfilariae From Skin by Skin Snips
The effectiveness of three treatment regimens for complete clearance of microfilariae from the skin as determined by skin snips at 3, 12, and 18 months after treatment with IDA will be compared by treatment arm.
Measured: Baseline, 3 months, 12 months, & 18 months following treatment.
Effectiveness for Preventing Reappearance of Microfilariae in the Skin by Skin Snips
The effectiveness of three treatment regimens for preventing reappearance of microfilariae in the skin as determined by skin snips at 12 and 18 months after treatment will be compared by treatment arm. Measured by the presence of microfilariae in skin snips.
Measured: Baseline, 12 months, and 18 months following treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 20191 Jun 2022

First posted5 Dec 2019
Study start6 Dec 2019
Primary completion14 Mar 2022
Study completion1 Jun 2022

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 (42)Papers the sponsor has linked to this study.
Other trials for OnchocerciasisStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe 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
Model description: Participants will be split into two strata - those without ocular Mf detected six months after ivermectin pretreatment in the Part I preceding study AND without ocular Mf detected at baseline in the part II study will be in stratum 1. Those participants with ocular Mf detected 6 months after ivermectin pretreatment in the preceding study OR with ocular Mf detected at the baseline exam for this study will be in stratum 2. Stratum 1 will be enrolled first, followed by stratum 2. Members of each stratum will be evenly randomized into one of three treatment arms: 1. IVM + ALB - Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB) 2. IDA x 1 dose - Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) 3. IDA x 3 doses -Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04188301
Sponsor's protocol ID: 201910085
Acronym: DOLF IDA/Oncho
Status last verified: Jun 2024
First submitted: 2 Dec 2019
Last updated: 4 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Datasets used for published results will be shared publicly through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.

Publications

Herricks JR, Hotez PJ, Wanga V, Coffeng LE, Haagsma JA, Basanez MG, Buckle G, Budke CM, Carabin H, Fevre EM, Furst T, Halasa YA, King CH, Murdoch ME, Ramaiah KD, Shepard DS, Stolk WA, Undurraga EA, Stanaway JD, Naghavi M, Murray CJL. The global burden of disease study 2013: What does it mean for the NTDs? PLoS Negl Trop Dis. 2017 Aug 3;11(8):e0005424. doi: 10.1371/journal.pntd.0005424. eCollection 2017 Aug. No abstract available.
PubMed 28771480
Taylor MJ, Awadzi K, Basanez MG, Biritwum N, Boakye D, Boatin B, Bockarie M, Churcher TS, Debrah A, Edwards G, Hoerauf A, Mand S, Matthews G, Osei-Atweneboana M, Prichard RK, Wanji S, Adjei O. Onchocerciasis Control: Vision for the Future from a Ghanian perspective. Parasit Vectors. 2009 Jan 21;2(1):7. doi: 10.1186/1756-3305-2-7.
PubMed 19154624
Zimmerman PA, Dadzie KY, De Sole G, Remme J, Alley ES, Unnasch TR. Onchocerca volvulus DNA probe classification correlates with epidemiologic patterns of blindness. J Infect Dis. 1992 May;165(5):964-8. doi: 10.1093/infdis/165.5.964.
PubMed 1569351
Fischer P, Kipp W, Bamuhiga J, Binta-Kahwa J, Kiefer A, Buttner DW. Parasitological and clinical characterization of Simulium neavei-transmitted onchocerciasis in western Uganda. Trop Med Parasitol. 1993 Dec;44(4):311-21.
PubMed 8134773
Dadzie KY, Bird AC, Awadzi K, Schulz-Key H, Gilles HM, Aziz MA. Ocular findings in a double-blind study of ivermectin versus diethylcarbamazine versus placebo in the treatment of onchocerciasis. Br J Ophthalmol. 1987 Feb;71(2):78-85. doi: 10.1136/bjo.71.2.78.
PubMed 3548811
Semba RD, Donnelly JJ, Young E, Green WR, Scott AL, Taylor HR. Experimental ocular onchocerciasis in cynomolgus monkeys. IV. Chorioretinitis elicited by Onchocerca volvulus microfilariae. Invest Ophthalmol Vis Sci. 1991 Apr;32(5):1499-507.
PubMed 2016131
Taylor HR. Onchocerciasis. Int Ophthalmol. 1990 May;14(3):189-94. doi: 10.1007/BF00158317.
PubMed 2188920
Bird AC, el-Sheikh H, Anderson J, Fuglsang H. Changes in visual function and in the posterior segment of the eye during treatment of onchocerciasis with diethylcarbamazine citrate. Br J Ophthalmol. 1980 Mar;64(3):191-200. doi: 10.1136/bjo.64.3.191.
PubMed 7387952
Duke BO. Human onchocerciasis--an overview of the disease. Acta Leiden. 1990;59(1-2):9-24.
PubMed 2198761
Braun G, McKechnie NM, Connor V, Gilbert CE, Engelbrecht F, Whitworth JA, Taylor DW. Immunological crossreactivity between a cloned antigen of Onchocerca volvulus and a component of the retinal pigment epithelium. J Exp Med. 1991 Jul 1;174(1):169-77. doi: 10.1084/jem.174.1.169.
PubMed 2056276
Chandrashekar R, Curtis KC, Weil GJ. Molecular characterization of a parasite antigen in sera from onchocerciasis patients that is immunologically cross-reactive with human keratin. J Infect Dis. 1995 Jun;171(6):1586-92. doi: 10.1093/infdis/171.6.1586.
PubMed 7539474
Chandrashekar R, Ogunrinade AF, Alvarez RM, Kale OO, Weil GJ. Circulating immune complex-associated parasite antigens in human onchocerciasis. J Infect Dis. 1990 Nov;162(5):1159-64. doi: 10.1093/infdis/162.5.1159.
PubMed 2230240
Greene BM, Gbakima AA, Albiez EJ, Taylor HR. Humoral and cellular immune responses to Onchocerca volvulus infection in humans. Rev Infect Dis. 1985 Nov-Dec;7(6):789-95. doi: 10.1093/clinids/7.6.789.
PubMed 4070916
Johnson TP, Tyagi R, Lee PR, Lee MH, Johnson KR, Kowalak J, Elkahloun A, Medynets M, Hategan A, Kubofcik J, Sejvar J, Ratto J, Bunga S, Makumbi I, Aceng JR, Nutman TB, Dowell SF, Nath A. Nodding syndrome may be an autoimmune reaction to the parasitic worm Onchocerca volvulus. Sci Transl Med. 2017 Feb 15;9(377):eaaf6953. doi: 10.1126/scitranslmed.aaf6953.
PubMed 28202777
Kawabata M, Izui S, Anan S, Kondo S, Fukumoto S, Flores GZ, Kobayakawa T. Circulating immune complexes and their possible relevance to other immunological parameters in Guatemalan onchocerciasis. Int Arch Allergy Appl Immunol. 1983;72(2):128-33. doi: 10.1159/000234854.
PubMed 6874107

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Active, not recruitingPhase 3
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
Onchocerciasis
Active, not recruitingPhase 2
Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis
Onchocercal Subcutaneous Nodule, Onchocerciasis

All Onchocerciasis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Combination Therapy With Ivermectin, Diethylcarbamazine, and Albendazole (IDA) for Individuals With Onchocerciasis
ClinicalTrials.gov ID: NCT04188301
Acronym / sponsor ID: DOLF IDA/Oncho / 201910085
Conditions: Onchocerciasis
Keywords: ophthalmology
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Case Western Reserve University, University of Health and Allied Sciences
Study start: 6 Dec 2019 (actual)
Primary completion: 14 Mar 2022 (actual)
Study completion: 1 Jun 2022 (actual)
First posted: 5 Dec 2019 (actual)
Results: Posted 10 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary objectives:

Safety: To compare rates and types of severe adverse events (grade 3 or higher) that occur within 7 days following 1 day or 3 days of treatment with triple drug treatment ("IDA" = diethylcarbamazine (DEC) with ivermectin (IVM) and albendazole (ALB)) with the comparator regimen of 1 day of treatment with ivermectin and albendazole (IA) in persons with active Onchocerca volvulus infections after pretreatment with ivermectin alone.
Efficacy: To compare the effect of three treatment regimens (1 day of IDA, 3 days of IDA, or IA) for killing or sterilizing adult female O. volvulus worms based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment.

This is an open label, randomized clinical trial.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Participants will be split into two strata - those without ocular Mf detected six months after ivermectin pretreatment in the Part I preceding study AND without ocular Mf detected at baseline in the part II study will be in stratum 1. Those participants with ocular Mf detected 6 months after ivermectin pretreatment in the preceding study OR with ocular Mf detected at the baseline exam for this study will be in stratum 2. Stratum 1 will be enrolled first, followed by stratum 2. Members of each stratum will be evenly randomized into one of three treatment arms: 1. IVM + ALB - Single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB) 2. IDA x 1 dose - Single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg) 3. IDA x 3 doses -Once daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Arm	Type	Receives
IVM + ALB	Active comparator	Drug: IVM w/ ALBSingle dose of oral IVM (150 µg/kg) plus ALB (400 mg)
IDA x 1 dose	Experimental	Drug: Single dose of IDASingle dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
IDA x 3 doses	Experimental	Drug: Three daily doses of IDAOnce daily for 3 days oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)

Who may qualify

Ages: 16 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Men and women who were previously enrolled in the preceding Part I study (Protocol ID#201804116) and residing in the study area
Must have at least palpable subcutaneous nodule (onchocercoma)
Participants with baseline skin Mf counts less than or equal to 3 Mf/mg at the time of enrollment into the Part I study (Protocol ID#201804116)

Key exclusion criteria (27 listed)

Pregnant and breastfeeding mothers within 1 month of giving birth
Severe eye disease at baseline including uveitis, severe glaucoma, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye as well as the list of ocular diseases as outlined below. All ocular disease exclusion criteria apply to either eye. Bilateral disease is not necessary to exclude a participant. A participant will be excluded if any of the criteria are met for one eye.
Significant comorbidities such as renal insufficiency, liver failure, or any other acute or chronic illness identified by study clinicians and investigators that interferes with the participant's ability to go to school or work or perform routine household chores.
Prior allergic / hypersensitivity reactions or intolerance to IVM, ALB, or DEC.
Treatment with IVM outside of the study after the pre-treatment clearing dose provided in the Part I study.

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
IVM w/ ALBAlso: IAParticipants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)	Drug	IVM + ALB
Single dose of IDAAlso: IVM/DEC/ALB (x1)Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)	Drug	IDA x 1 dose
Three daily doses of IDAAlso: IVM/DEC/ALB (x3)Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)	Drug	IDA x 3 doses

Primary outcome

Rates of Severe Adverse Events (SAEs) Across Study Arms
Time frame: Within 7 days following end of treatment
Rates of severe adverse events (grade 3 or higher) following 1-day or 3-day triple drug treatment will be compared against those of the comparator regimen of 1 day of IVM/ALB.
Percentage of Worms Killed Across Study Arms
Time frame: 18 months following treatment.
The effect of three treatment regimens for killing adult female O. volvulus worms will be compared based on the percentage of all adult female worms in nodules that are alive with embryos in the uterus 18 months after treatment.
Percentage of Worms Sterilized Across Study Arms
Time frame: 18 months following treatment.
The effect of three treatment regimens for sterilizing adult female O. volvulus worms will be compared based on the percentage of all adult female worms that are fertile in the nodules 18 months after treatment.

5 secondary outcomes

Rates of SAEs by Treatment Group in Those With Intraocular Microfilariae Just Prior to Treatment With IDA
Time frame: within 7 days following end of treatment
Rates of Ocular Adverse Events (Any Grade) by Treatment Group
Time frame: within 3 months of treatment with IDA
Effectiveness of Killing Adult Female Worms
Time frame: 18 months following treatment
Effectiveness of Clearing Microfilariae From Skin by Skin Snips
Time frame: Baseline, 3 months, 12 months, & 18 months following treatment.
Effectiveness for Preventing Reappearance of Microfilariae in the Skin by Skin Snips
Time frame: Baseline, 12 months, and 18 months following treatment

Results and safety

Results posted to the registry on 10 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IVM + ALB	52	52
IDA x 1 Dose	51	51
IDA x 3 Doses	51	51

Primary outcome: Rates of Severe Adverse Events (SAEs) Across Study Arms

Time frame: Within 7 days following end of treatment. Count of participants. Unit: Participants

Measure	IVM + ALB n = 52	IDA x 1 Dose n = 51	IDA x 3 Doses n = 51
Value	0	0	0

Primary outcome: Percentage of Worms Killed Across Study Arms

Time frame: 18 months following treatment.. Count of units. Unit: Female worms in nodules

Measure	IVM + ALB n = 41	IDA x 1 Dose n = 46	IDA x 3 Doses n = 47
Value	127	142	159

IVM + ALB vs IDA x 1 Dose: Odds Ratio (OR): 1.41 (95% CI 0.84 to 2.38), p = 0.192, Regression, Logistic
IVM + ALB vs IDA x 3 Doses: Odds Ratio (OR): 1.45 (95% CI 0.92 to 2.29), p = 0.107, Regression, Logistic
IVM + ALB vs IDA x 1 Dose vs IDA x 3 Doses: Odds Ratio (OR): 1.44 (95% CI 0.97 to 2.15), p = 0.068, Regression, Logistic

Population analysed: The analysis was conducted on worms from participants who had nodulectomies conducted at 18 months. Not all participants who completed the study had nodulectomies conducted.

Primary outcome: Percentage of Worms Sterilized Across Study Arms

Time frame: 18 months following treatment.. Count of units. Unit: Female worms with intact uterus

Measure	IVM + ALB n = 41	IDA x 1 Dose n = 46	IDA x 3 Doses n = 47
Value	41	40	34

IVM + ALB vs IDA x 1 Dose: Odds Ratio (OR): 1.66 (95% CI 0.85 to 3.21), p = 0.134, Regression, Logistic
IVM + ALB vs IDA x 3 Doses: Odds Ratio (OR): 2.23 (95% CI 1.12 to 4.44), p = 0.023, Regression, Logistic
IDA x 1 Dose vs IDA x 3 Doses: Odds Ratio (OR): 1.32 (95% CI .64 to 2.85), p = 0.430, Regression, Logistic

Population analysed: The analysis was conducted on worms from participants who had nodulectomies conducted at 18 months. Not all participants who completed the study had nodulectomies conducted. Female worms were excluded who had collapsed uteri that could not be evaluated for fertility.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data was collected on adverse events for safety from baseline to 3 months after treatment. Serious adverse events and mortality were collected throughout the trial from baseline to 18 months after treatment.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IVM + ALB	0 of 52 (0%)	11 of 52 (21.2%)	1 of 52
IDA x 1 Dose	0 of 51 (0%)	15 of 51 (29.4%)	1 of 51
IDA x 3 Doses	0 of 51 (0%)	11 of 51 (21.6%)	0 of 51

Limitations and caveats (from the sponsor): Pause on clinical trial operations between March 2020 - June 2020 due to the COVID-19 pandemic. Decreased health and viability of the adult female worm population in participants may have reduced the study's ability to detect a significant macrofilaricidal effect of IDA. Study enrolled participants with light/moderate infections, which greatly decreased the risk of SAEs occurring. Future studies to assess tolerability of IDA would need to be conducted with higher infection rates.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28771480Herricks JR, Hotez PJ, Wanga V, Coffeng LE, Haagsma JA, Basanez MG, Buckle G, Budke CM, Carabin H, Fevre EM, Furst T, Halasa YA, King CH, Murdoch ME, Ramaiah KD, Shepard DS, Stolk WA, Undurraga EA, Stanaway JD, Naghavi M, Murray CJL. The global burden of disease study 2013: What does it mean for the NTDs? PLoS Negl Trop Dis. 2017 Aug 3;11(8):e0005424. doi: 10.1371/journal.pntd.0005424. eCollection 2017 Aug. No abstract available.
Background: PubMed 19154624Taylor MJ, Awadzi K, Basanez MG, Biritwum N, Boakye D, Boatin B, Bockarie M, Churcher TS, Debrah A, Edwards G, Hoerauf A, Mand S, Matthews G, Osei-Atweneboana M, Prichard RK, Wanji S, Adjei O. Onchocerciasis Control: Vision for the Future from a Ghanian perspective. Parasit Vectors. 2009 Jan 21;2(1):7. doi: 10.1186/1756-3305-2-7.
Background: PubMed 1569351Zimmerman PA, Dadzie KY, De Sole G, Remme J, Alley ES, Unnasch TR. Onchocerca volvulus DNA probe classification correlates with epidemiologic patterns of blindness. J Infect Dis. 1992 May;165(5):964-8. doi: 10.1093/infdis/165.5.964.
Background: PubMed 8134773Fischer P, Kipp W, Bamuhiga J, Binta-Kahwa J, Kiefer A, Buttner DW. Parasitological and clinical characterization of Simulium neavei-transmitted onchocerciasis in western Uganda. Trop Med Parasitol. 1993 Dec;44(4):311-21.
Background: PubMed 3548811Dadzie KY, Bird AC, Awadzi K, Schulz-Key H, Gilles HM, Aziz MA. Ocular findings in a double-blind study of ivermectin versus diethylcarbamazine versus placebo in the treatment of onchocerciasis. Br J Ophthalmol. 1987 Feb;71(2):78-85. doi: 10.1136/bjo.71.2.78.
Background: PubMed 2016131Semba RD, Donnelly JJ, Young E, Green WR, Scott AL, Taylor HR. Experimental ocular onchocerciasis in cynomolgus monkeys. IV. Chorioretinitis elicited by Onchocerca volvulus microfilariae. Invest Ophthalmol Vis Sci. 1991 Apr;32(5):1499-507.
Background: PubMed 2188920Taylor HR. Onchocerciasis. Int Ophthalmol. 1990 May;14(3):189-94. doi: 10.1007/BF00158317.
Background: PubMed 7387952Bird AC, el-Sheikh H, Anderson J, Fuglsang H. Changes in visual function and in the posterior segment of the eye during treatment of onchocerciasis with diethylcarbamazine citrate. Br J Ophthalmol. 1980 Mar;64(3):191-200. doi: 10.1136/bjo.64.3.191.
Background: PubMed 2198761Duke BO. Human onchocerciasis--an overview of the disease. Acta Leiden. 1990;59(1-2):9-24.
Background: PubMed 2056276Braun G, McKechnie NM, Connor V, Gilbert CE, Engelbrecht F, Whitworth JA, Taylor DW. Immunological crossreactivity between a cloned antigen of Onchocerca volvulus and a component of the retinal pigment epithelium. J Exp Med. 1991 Jul 1;174(1):169-77. doi: 10.1084/jem.174.1.169.
Background: PubMed 7539474Chandrashekar R, Curtis KC, Weil GJ. Molecular characterization of a parasite antigen in sera from onchocerciasis patients that is immunologically cross-reactive with human keratin. J Infect Dis. 1995 Jun;171(6):1586-92. doi: 10.1093/infdis/171.6.1586.
Background: PubMed 2230240Chandrashekar R, Ogunrinade AF, Alvarez RM, Kale OO, Weil GJ. Circulating immune complex-associated parasite antigens in human onchocerciasis. J Infect Dis. 1990 Nov;162(5):1159-64. doi: 10.1093/infdis/162.5.1159.
Individual participant dataSharing planned: Yes. Datasets used for published results will be shared publicly through a journal or other open source data repository so that the broader scientific community can access it. Only de-identified data will be shared publicly.

Related trials for Onchocerciasis

Active, not recruitingObservational study
Host Response to Infection and Treatment in Filarial Diseases
Filariasis, Helminthiasis
Recruiting
Expanding Access to Preventive Chemotherapy Among Mobile and Migrant Populations
Onchocerciasis (River Blindness), Schistosomiasis
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
Active, not recruitingPhase 3
Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis
Onchocerciasis
Active, not recruitingPhase 2
Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis
Onchocercal Subcutaneous Nodule, Onchocerciasis

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.

Gary Weil, MD principal investigator

Washington University School of Medicine

Christopher King, MD, PhD principal investigator

Case Western Reserve University

Nicholas Opoku, MB, CHB, MSC principal investigator

University of Health and Allied Sciences, Hohoe, Ghana

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 IVM w/ ALB, Single dose of IDA and Three daily doses of IDA in people with Onchocerciasis, run by Washington University School of Medicine at 1 site in Ghana.

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 3 inclusion and 27 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 4 Jun 2024. 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 Ghana. 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 10 May 2023). 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?

Rates of Severe Adverse Events (SAEs) Across Study Arms (time frame: Within 7 days following end of treatment). The study lists 3 primary outcomes in all. 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 NCT04188301, which also lists 42 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 4 Jun 2024.