Completed PHASE3 INTERVENTIONAL 4-arm NCT00696969

Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis

Randomized, Open-label, Parallel-group, Safety & Efficacy Study to Evaluate Different Combination Treatment Regimens, of Either AmBisome and Paromomycin, AmBisome and Miltefosine, or Paromomycin and Miltefosine Compared With Amphotericin B Deoxycholate (the Standard) Therapy for the Treatment of Acute, Symptomatic Visceral Leishmaniasis (VL).

Sponsor: Drugs for Neglected Diseases

Conditions Visceral Leishmaniasis

Interventions Ambisome + Miltefosine Ambisome and Paromomycin Amphotericin B Deoxycholate Miltefosine and Paromomycin

Updated 5 times since 2017 Last updated: Feb 10, 2010 Started: Jun 30, 2008 Primary completion: Jan 31, 2010 Completion: Jan 31, 2010

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Visceral Leishmaniasis and is currently completed. Drugs for Neglected Diseases leads this study, which shows 5 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Jun 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Drugs for Neglected Diseases

Data source: Drugs for Neglected Diseases

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Muzaffarpur, India
• Patna, India