Clinical Trials Logo
  1. Home
  2. Onchocerciasis
  3. NCT04188301

Safety and Efficacy of IDA for Onchocerciasis — DOLF IDA/Oncho  

Onchocerciasis Clinical Trial

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

Clinical 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04188301
Study type Interventional
Source Washington University School of Medicine
Contact
Status Completed
Phase Phase 2
Start date December 6, 2019
Completion date June 1, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT00300768 - Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection Phase 2
Not yet recruiting NCT04035174 - Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa N/A
Recruiting NCT03653975 - Clinical Features and Potential Etiology of Epilepsy and Nodding Syndrome in the Mahenge Area, Ulanga District
Completed NCT03052998 - Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy Phase 4
Active, not recruiting NCT03876262 - Safety and Efficacy of Annual or Biannual Doses of Moxidectin or Ivermectin for Onchocerciasis Phase 3
Active, not recruiting NCT04311671 - Safety of a Single Dose of Moxidectin Compared With 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 Phase 3
Terminated NCT04913610 - Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection Phase 2
Completed NCT03962062 - A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years Phase 1
Completed NCT01905436 - Mass Drug Administration for Lymphatic Filariasis and Onchocerciasis for Liberia
Recruiting NCT00001230 - Host Response to Infection and Treatment in Filarial Diseases
Completed NCT05750043 - Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan
Completed NCT05749653 - Impact of a Bi-annual CDTI on the Incidence of Epilepsy in an Onchocerciasis-endemic Area N/A
Completed NCT02078024 - Efficacy of Ivermectin and Albendazole Against Onchocerciasis in the Volta Region, Ghana Phase 3
Completed NCT00127504 - Clinical Trial of Rifampin and Azithromycin for the Treatment of River Blindness Phase 2
Completed NCT03131401 - Prevalence of LF Infection in Districts Not Included in LF Control Activities
Completed NCT02032043 - Optimization of Mass Drug Administration With Existing Drug Regimens for Lymphatic Filariasis and Onchocerciasis for Ivory Coast (DOLF-Ivory Coast)
Terminated NCT05084560 - Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug Phase 1
Completed NCT03517462 - Ocular Changes After Ivermectin - (DOLF IVM/Oncho) N/A
Active, not recruiting NCT05180461 - Emodepside Phase II Trial for Treatment of Onchocerciasis Phase 2
Enrolling by invitation NCT06070116 - Safety and Efficacy of Novel Combination Regimens for Treatment of Onchocerciasis Phase 2