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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01975441
Other study ID # CWRU 3 vs 2 LF ELIM PNG
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2014
Est. completion date June 2018

Study information

Verified date October 2018
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will determine if a combination of 3 drugs used to treat the infection that cause lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM) and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to treat LF.


Description:

This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF infected subjects (>50 Mf/ml) at 36 months post-treatment. This study also tests the hypothesis that single dose of triple drug is super in sustained clearance of microfilariae compared to single dose of DEC/ALB.

There will be 3 treatment arms as follows:

1. The comparator (standard treatment) DEC 6 mg/kg + Alb 400 mg administered annually (at 0, 12, and 24 months).

2. DEC 6 mg/kg + Alb 400 mg given once

3. DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the RCT (0 month).


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date June 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Men and women 18-65 years

- >50 mf/ml in finger stick blood samples

- Willing to give informed consent

Exclusion Criteria:

- Prior treatment for LF within last 5 years

- Pregnant (do pregnancy test)

- Hemoglobin < 7 g/dl

- permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension

- AST/ALT and creatinine > 1.5 upper limit of normal.

- Urine dipstick with glucose = 2+ and/or protein = 2+

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Diethylcarbamazine
Diethylcarbamazine 6mg/kg
Albendazole
Albendazole 400mg
Ivermectin
Ivermectin 200 mcg/kg

Locations

Country Name City State
Papua New Guinea Papua New Guinean Institute for Medical Research Maprik East Sepik

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

Papua New Guinea, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of subjects with total clearance of in Wuchereria bancrofti (Wb) microfilaria (mf) at 36 months
Secondary Percentage of subjects with total clearance of Mf at 24 months. 24 months
Secondary Percent reduction in W. bancrofti antigen levels compared to baseline measured at 24 and 36 months 24 months and 36 months
Secondary Percent of subjects who become circulating antigen negative at 24 months and 36 months after the beginning of the study 24 months and 36 months
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