A Phase 2/3 interventional study of Levamisole 3 days and Levamisole 5 days in Loiasis, sponsored by Programme National de Lutte contre l'Onchocercose, Republic of the Congo. Recruiting at 2 sites in Congo. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Programme National de Lutte contre l'Onchocercose, Republic of the Congo · Phase 2/3, Interventional, and Treatment
The aim of the study is to evaluate the safety and efficacy of a 3- and 5-day course of levamisole (2.5 mg/kg) in management of loiasis microfilaremia.
Onchocerciasis and loiasis are parasitic diseases caused by Onchocerca volvulus and Loa loa, respectively.
Onchocerciasis is endemic in 31 African countries, parts of South America, and Yemen, affecting around 37 million people, while loiasis is present in Central Africa, infecting approximately 15 million individuals. Both diseases are associated with severe complications and increased mortality.
African countries have implemented mass drug administration (MDA) programs using ivermectin to combat onchocerciasis. However, co-endemic loiasis poses challenges due to the risk of severe adverse events. Current strategies involve alternative treatments and chemoprophylaxis to accelerate onchocerciasis elimination. The project aims to evaluate the use of levamisole as an alternative treatment.
This project will assess the safety and efficacy of administering levamisole for 3 and 5 days to reduce Loa microfilarial density. Previous research demonstrated the safety of a single dose of levamisole but indicated the need for longer treatment regimens to achieve a significant reduction in Loa microfilarial density. The project aims to test whether 3- and 5-day levamisole regimens induce an acceptable safety profile and a stronger reduction in Loa microfilarial density.
35 studies on the registry are indexed under Onchocerciasis; 7 are open to participants now.
This study's planned enrollment of 99 is below the median of 216 across 26 interventional studies indexed under Onchocerciasis.
Browse Onchocerciasis studies →Programme National de Lutte contre l'Onchocercose, Republic of the Congo is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized in this arm will receive 3 days of levamisole 2.5mg/kg, followed by 2 days of placebo
Drug: Levamisole 3 days
Participants randomized in this arm will receive a 5-day course of levamisole 2.5mg/kg
Drug: Levamisole 5 days
Participants randomized in this arm will receive 5 days of placebo
Drug: Placebo
Levamisole for 3 days (2,5 mg/kg) then placebo for 2 days
Levamisole for 5 days (2,5 mg/kg)
Placebo for 5 days
Tolerance of multiple doses of levamisole 2.5 mg/kg in individuals with Loa loa microfilaremia
The proportions of adverse reactions and severe adverse reactions between the three arms of study will be compared, as well as between each interventional arm versus placebo, using appropriate comparative tests A multivariate analysis may be envisaged to assess the influence of age, gender and the presence or absence of M. perstans on the proportion of AEs
Time frame: During the treatment (5 days) and 2 weeks after
Efficacy of multiple doses of levamisole 2.5 mg/kg on Loa loa microfilaremia
Microfilaremia reduction rates will be compared between arms at Day 3, Day 5, Day 7, Day 15 and Day 30. The proportions of subjects who had reduced their microfiflaremia by at least 80% at D3, D5, D7, D15 and D30 will be compared Finally, a multivariate analysis could be carried out to assess the influence of age, gender and the presence or absence of M. perstans on the reduction of the microfilaremia.
Time frame: From Day 3 after the first dose to Day 30 after the first dose
Plan to share: No
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Programme National de Lutte contre l'Onchocercose, Republic of the Congo