Clinical Trial: Pharmacokinetics & Pharmacodynamics of Diethylcarbamazine (DEC)+ Albendazole (ALB) + Ivermectin (IVE)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Single Dose Treatment With Diethylcarbamazine, Albendazole and Ivermectin in Humans With and Without Wuchereria Ban

Brief Summary:

The study will be an open label cohort study with 2 two-treatment groups 2). Both groups will be treated with a single oral administration of Diethylcarbamazine (DEC) 6 mg/kg + Albendazole (ALB) 400 mg + Ivermectin (IVR) 200 µg/kg (IDA). One treatment group will include men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will include men and women who are free of W. bancrofti infection based on negative blood tests for both microfilariae (Mf) and circulating filarial antigen (N=30). Active follow-up for adverse events (AE) will be for 72hrs and passive follow-up for 7 days following treatment.

Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital and cared for by the hospital staff. Based on treatment of over 100 Lymphatic filariasis (LF) infected individuals any AEs develop within the first 72 hours following treatment and uncommonly up to 7 days post-treatment.

All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.

Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling for drug analyses and safety tests. Participants will undergo clinical monitoring every 6 hours to evaluate potential adverse effects of Ivermectin + Diethylcarbamazine + Albendazole (IDA) treatment. Participants will also be monitored for hematologic, or biochemical abnormalities during the period of observation.


Detailed Summary:

The study will be an open label cohort study with 2 two-treatment groups. Both groups will be treated with a single oral administration of DEC 6 mg/kg + ALB 400 mg + IVR 200 µg/kg (IDA). One treatment group will include men and women with W. bancrofti infections (>50 Mf/ml, N=30). The other treatment group will include men and women who are free of W. bancrofti infection based on negative blood tests for both microfilariae and circulating filarial antigen (N=30). Active follow-up for adverse events (AE) will be for 72 hours and passive follow-up for 7 days following treatment.

Participants will be followed again at 1 year to evaluate treatment efficacy. Individuals with severe AEs (grade 3 or higher) will be transported to the Agboville District Hospital and cared for by the hospital staff. Based on treatment of over 100 LF infected individuals any AEs develop within the first 72 hours following treatment and uncommonly up to 7 days post-treatment.

All individuals will be admitted to a single health center or hospital in Côte d'Ivoire.

Subjects will be monitored for 72-hours after treatment for safety and to facilitate sampling for drug analyses and safety tests. Participants will undergo clinical monitoring every 6 hours to evaluate potential adverse effects of IDA treatment. Participants will also be monitored for hematologic, or biochemical abnormalities during the period of observation.

At enrollment all subjects will be otherwise healthy adult men and women (≥18-65 years of age). All individuals will be assessed for the presence and burden of geohelminth infections, parasitic worms of the gastrointestinal tract such as hookworm, Trichuris trichiuria and Ascaris lumbricoides. This is important because
Sponsor: University Hospitals Cleveland Medical Center

Current Primary Outcome: Drug Levels [ Time Frame: up to 12 hours ]

Five mil-liters of blood will be taken to test drug levels


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (aggregate) [ Time Frame: up to 1 year ]
    Following drug administration, a review of subjective symptoms will be performed.
  • Impact of treatment on Hematuria and Proteinuria [ Time Frame: up to 7 days ]
    Urine samples will be collected to examine the the presence and amount of blood and protein in the urine.
  • Number worm nests [ Time Frame: up to 1 year ]
    In those individuals with LF, an ultrasound examination will be performed to identify the number of adult worm nests both before treatment and after.
  • Impact of treatment on Liver Function + [ Time Frame: up to 7 days ]
    Blood samples will be collected to examine the impact of treatment on the levels of ALT, AST in the subjects blood.
  • Impact of treatment on Hemoglobin Levels [ Time Frame: up to 7 days ]
    Blood samples will be collected to examine the impact of treatment on the levels of Hemoglobin in the subjects blood.
  • Impact of treatment on White Blood Cells [ Time Frame: up to 7 days ]
    Blood samples will be collected to examine the impact of treatment on the levels of white blood count in subjects blood.


Original Secondary Outcome: Same as current

Information By: University Hospitals Cleveland Medical Center

Dates:
Date Received: June 3, 2016
Date Started: April 2016
Date Completion: July 2017
Last Updated: May 2, 2017
Last Verified: May 2017