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Last Updated: February 9, 2023

CLINICAL TRIALS PROFILE FOR PAROMOMYCIN SULFATE


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All Clinical Trials for Paromomycin Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000771 ↗ A Double-Blind, Placebo-Controlled Trial of Paromomycin for Treatment of Cryptosporidiosis in Patients With Advanced HIV Disease and CD4 Counts Under 150 Cells/mm3 Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To determine the effectiveness of oral paromomycin sulfate for 21 days compared to placebo in the treatment of cryptosporidiosis in patients with HIV infection. To evaluate the safety of oral paromomycin at two different doses. To explore whether paromomycin administered over a longer period provides additional benefit. In previous studies, patients with cryptosporidiosis demonstrated dramatic improvement with paromomycin therapy.
NCT00001128 ↗ Treatment of Chronic Cryptosporidiosis in AIDS Patients Terminated Genetics Institute N/A 1969-12-31 The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone. Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.
NCT00001128 ↗ Treatment of Chronic Cryptosporidiosis in AIDS Patients Terminated National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to see if it is safe and effective to add interleukin-12 (IL-12) to the standard drug combination (paromomycin plus azithromycin) used to treat cryptosporidiosis in AIDS patients. Doctors would like to find out if the combination of IL-12, paromomycin, and azithromycin is more effective than paromomycin and azithromycin alone. Cryptosporidiosis is a type of opportunistic (AIDS-related) infection seen in HIV-positive patients as their immune systems weaken. It is caused by a parasite that invades the intestinal tract, and it can cause watery diarrhea, stomach cramps, an upset stomach, or a fever. Antibiotics (paromomycin and azithromycin) are usually used to treat cryptosporidiosis. In this study, doctors will look at the effectiveness of using IL-12. IL-12 is a type of protein naturally produced by certain types of cells of the immune system and is believed to be important for immune function. Doctors hope that IL-12 can help boost the immune system in fighting cryptosporidiosis.
NCT00216346 ↗ Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis Completed World Health Organization Phase 3 2003-06-01 Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
NCT00216346 ↗ Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis Completed PATH Phase 3 2003-06-01 Symptomatic Visceral Leishmaniasis(VL)is fatal; Due to the increasing resistance to standard therapy with antimonials, there is a need for new safe, efficacious, low-cost therapies for the treatment of VL. Paromomycin is an off-patent aminoglycoside antibiotic with anti-leishmaniasis activity. This study will test the safety and efficacy of paromomycin in the treatment of patients with VL in India.
NCT00604955 ↗ Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis Completed PATH Phase 4 2007-10-01 This modular Program will first confirm the safety and efficacy of Paromomycin IM Injection when given to an expanded population in the outpatient setting in experienced VL centers and subsequently evaluate the effectiveness of an expanded access model of providing Paromomycin IM Injection to progressively more resource-constrained clinics in Bihar, India.
NCT01050777 ↗ Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis Completed Center for Research and Training in Skin Diseases and Leprosy Early Phase 1 2011-03-01 Leishmaniasis with diverse clinical manifestations is caused by different species of Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the first-line treatment of CL which needs multiple injections, are painful and as such not tolerated by most of the patients, in addition available treatments are not always effective and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in proper formulations and sizes, deliver drugs to the skin based on the similarity of the bilayers structure of lipid vesicles to that of natural membrane and target the macrophages within dermis. Several lipid-based formulations have been developed to treat experimental leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal formulation of Glucantime were prepared and showed high efficacy in vivo against L. major infection in BALB/c mice. In this study the efficacy of liposomal formulation of PM or liposomal formulation of Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically proven patients will be evaluated. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Paromomycin Sulfate

Condition Name

Condition Name for Paromomycin Sulfate
Intervention Trials
Visceral Leishmaniasis 4
Cryptosporidiosis 2
HIV Infections 2
Leishmaniasis; American, Cutaneous 1
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Condition MeSH

Condition MeSH for Paromomycin Sulfate
Intervention Trials
Leishmaniasis 6
Leishmaniasis, Visceral 4
Leishmaniasis, Cutaneous 2
HIV Infections 2
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Clinical Trial Locations for Paromomycin Sulfate

Trials by Country

Trials by Country for Paromomycin Sulfate
Location Trials
United States 8
India 3
Bolivia 2
Sudan 2
Bangladesh 2
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Trials by US State

Trials by US State for Paromomycin Sulfate
Location Trials
Indiana 1
Illinois 1
Florida 1
California 1
Texas 1
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Clinical Trial Progress for Paromomycin Sulfate

Clinical Trial Phase

Clinical Trial Phase for Paromomycin Sulfate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Paromomycin Sulfate
Clinical Trial Phase Trials
Completed 7
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Paromomycin Sulfate

Sponsor Name

Sponsor Name for Paromomycin Sulfate
Sponsor Trials
PATH 3
National Institute of Allergy and Infectious Diseases (NIAID) 2
Shaheed Suhrawardy Medical College Hospital, Dhaka, Bangladesh 1
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Sponsor Type

Sponsor Type for Paromomycin Sulfate
Sponsor Trials
Other 20
NIH 2
Industry 1
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