Onchocerciasis
Conditions
Brief summary
The purpose of this phase 3b study is to determine the safety of a single dose of moxidectin, compared to a single dose of ivermectin, in individuals living in onchocerciasis endemic areas and in individuals living in onchocerciasis endemic areas with high levels of lymphatic filariasis co-endemicity receiving concomitant albendazole.
Interventions
DRUGMoxidectin
2 mg tablets, encapsulated for blinding
DRUGIvermectin
3 mg tablets, encapsulated for blinding
DRUGAlbendazole
400 mg tablets
Sponsors
Medicines Development for Global Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Provision of written informed consent, or assent with parental or guardian written consent\* 2. Known O. volvulus skin microfilariae density ≥0 microfilariae/mg skin (participants ≥12 years of age only). 3. Living in an onchocerciasis endemic area. 4. Age ≥4 years 5. All female participants of childbearing potential must commit to the use of a reliable method of birth control until 3 months after administration of investigational product (Month 3). \* Expression of 'deliberate objection' will be the basis for assessing assent of children aged ≥ 4 to \<6 years
Exclusion criteria
1. Pregnant or breast-feeding. 2. Any concurrent condition that, in the opinion of the Investigator, would preclude evaluation of response to treatment or would pose undue risk to the participant's health. 3. Has received ivermectin or oral diethylcarbamazine (DEC) within 30 days of Baseline. 4. Has received treatment with an investigational agent within the 30 days (or 5 half-lives, whichever is longer) prior to planned investigational product administration. 5. Known or suspected allergy to ivermectin or moxidectin or their excipients and, in areas with high levels of LF co-endemicity, known or suspected allergy to albendazole and its excipients. 6. Self-reported planned or ongoing activities within the study period that would make it unlikely that the participant will be available for follow-up examinations. 7. Infection with Loa loa. 8. Height \<90 cm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Treatment Emergent Adverse Events | Up to 3 months | Participant incidence rates of treatment emergent adverse events following a single dose of moxidectin versus a single dose of ivermectin will be assessed separately by endemic area. Treatment emergent adverse events may also be pooled across both endemic areas (pooled monotherapy and combination therapies separately for moxidectin and ivermectin), provided a qualitative assessment shows they are similar enough to enable the interpretation of the pooled analysis. |
Countries
Côte d’Ivoire, Democratic Republic of the Congo
Contacts
PRINCIPAL_INVESTIGATORTony Ukety, MD, DO, MPH
Centre de Recherche en Maladies Tropicales de l'Ituri
PRINCIPAL_INVESTIGATORBenjamin Koudou, PhD
Centre Suisse de Recherches Scientifiques en Coˆte d'Ivoire
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 4203 Participants |
| Age, Categorical >=65 years | 627 Participants |
| Age, Categorical Between 18 and 65 years | 2409 Participants |
| Age, Continuous | 29.8 years |
| Number of participants with LF antigenemia and/or microfilaremia CFA negative | 3179 participants |
| Number of participants with LF antigenemia and/or microfilaremia CFA Positive (Category 1-3) with or without microfilaremia | 130 participants |
| Number of Participants with Onchocerca volvulus skin microfilariae (mf) Detectable (skin mf>0) | 555 participants |
| Number of Participants with Onchocerca volvulus skin microfilariae (mf) Overall tested | 11947 participants |
| Number of Participants with Onchocerca volvulus skin microfilariae (mf) Undetectable (skin mf =0) | 11392 participants |
| Race/Ethnicity, Customized Race - Black African | 1605 participants |
| Region of Enrollment Congo, The Democratic Republic of the | 8026 participants |
| Region of Enrollment Côte D'Ivoire | 4953 participants |
| Sex: Female, Male Female | 1829 Participants |
| Sex: Female, Male Male | 3467 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 6,421 | 2 / 1,605 | 3 / 3,959 | 0 / 994 | 9 / 10,380 | 2 / 2,599 |
| other Total, other adverse events | 346 / 6,421 | 79 / 1,605 | 1,199 / 3,959 | 288 / 994 | 1,545 / 10,380 | 367 / 2,599 |
| serious Total, serious adverse events | 18 / 6,421 | 4 / 1,605 | 4 / 3,959 | 0 / 994 | 22 / 10,380 | 4 / 2,599 |
Outcome results
None listed