Overview

Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
Summary
The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
U.S. Army Medical Research and Development Command
U.S. Army Medical Research and Materiel Command
Treatments:
Gentamicins
Paromomycin
Criteria
Inclusion Criteria:

- To be eligible for the study, the following must be answered "YES" or not applicable,
as appropriate for the study subject:

1. Is the subject a male or female at least 5 years-of-age?

2. Is the subject or legal guardian able to give written informed consent or assent,
as appropriate?

3. Does the subject have a diagnosis of CL in at least one lesion by at least one of
the following methods: 1) positive culture for promastigotes, or 2) microscopic
identification of amastigotes in stained lesion tissue.

4. Does the subject have at least one ulcerative lesion ≥ 1 cm and ≤ 5 cm, that
meets the criteria for an index lesion?

5. Is the subject willing to forego other forms of treatments for CL including other
investigational treatments during the study?

6. In the opinion of the investigator, is the subject (or their legal guardian)
capable of understanding and complying with the protocol?

7. If female and of child-bearing potential, did the subject have a negative
pregnancy test during screening and agree to use an acceptable method of birth
control during the treatment phase and for 1 month after treatment is completed?

8. Does the subject have adequate venous access for blood draws?

Exclusion Criteria:

To be eligible for the study, the following must be answered "NO" or not applicable as
appropriate for the study subject:

1. Does the subject have only a single lesion whose characteristics include any of the
following: verrucous or nodular lesion (non-ulcerative), lesion <1 cm in its greatest
diameter, lesion in a location that in the opinion of the Investigator is difficult to
maintain application of study drugs topically?

2. Does the subject have a lesion due to leishmania that involves the mucosa or palate or
any signs of mucosal disease that might be due to leishmania?

3. Does the subject have signs and symptoms of disseminated disease in the opinion of the
Principal Investigator?

4. Does the subject have > 10 lesions?

5. Is the subject a female who is breast-feeding?

6. Does the subject have an active malignancy or history of solid, metastatic or
hematologic malignancy with the exception of basal or squamous cell carcinoma of the
skin that has been removed?

7. Does the subject have significant organ abnormality, chronic disease such as diabetes,
severe hearing loss, evidence of renal or hepatic dysfunction, or creatinine greater
than 15%, or aspartate aminotransferase (AST), or alanine aminotransferase (ALT)
greater than 1.5 times the above the upper limit of normal (ULN) as defined by the
clinical laboratory defined normal ranges?

8. Has the subject received treatment for leishmaniasis including any medication with
pentavalent antimony including sodium stibogluconate (Pentostam), meglumine
antimoniate (Glucantime); amphotericin B (including liposomal amphotericin B and
amphotericin B deoxycholate); or other medications containing paromomycin
(administered parenterally or topically) or methylbenzethonium chloride (MBCL);
gentamicin; fluconazole; ketoconazole; pentamidine; miltefosine, azithromycin or
allopurinol that was completed within 8 weeks of starting study treatments?

9. Does the subject have a history of known or suspected hypersensitivity or
idiosyncratic reactions to aminoglycosides?

10. Does the subject have any other topical disease/condition which would interfere with
the objectives of this study?