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Last Updated: September 16, 2021

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CLINICAL TRIALS PROFILE FOR MEFLOQUINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Mefloquine Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00694694 ↗ Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. Completed National Institute for Medical Research, Tanzania Phase 3 2008-06-01 This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination NCT00694694 ↗ Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. Completed London School of Hygiene and Tropical Medicine Phase 3 2008-06-01 This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Mefloquine Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00082576 ↗ Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa Completed Pfizer Phase 2/Phase 3 2004-06-01 The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
NCT00127998 ↗ Antimalarial Drug Resistance in Mali Completed Malaria Research and Training Center, Bamako, Mali N/A 2005-07-01 Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to: 1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested. 2. Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria 3. Measure drug levels at 3 days and correlate with efficacy results. 4. Examine early clinical, parasitologic, and clinical predictors of late treatment failure. 5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
NCT00127998 ↗ Antimalarial Drug Resistance in Mali Completed Centers for Disease Control and Prevention N/A 2005-07-01 Resistance of Plasmodium falciparum (malaria) to current antimalarial drugs and the continuing development of resistance to new antimalarial formulations is one of the major obstacles to effective malaria control and case management. Efficient, comprehensive and validated methods for monitoring drug resistance in advance of the development of resistance to the antimalarial drugs that are in use are urgently needed. Molecular markers of genetic polymorphisms that give rise to resistant P. falciparum parasites and methods in population genetics for evaluating the data can be valuable tools for monitoring drug resistance in the field. This study aims to: 1. Prospectively measure the in vivo response of P. falciparum malaria in Mali to several different antimalarial drugs and drug combinations: chloroquine (CQ), sulfadoxine-pyrimethamine (SP), amodiaquine (AQ), sulfadoxine-pyrimethamine in combination with amodiaquine (SP/AQ), amodiaquine in combination with artesunate (AQ/AS), sulfadoxine-pyrimethamine in combination with artesunate (SP/AS), and artemether-lumefantrine (Co-artem). In one site with preliminary data showing a high rate of P. falciparum resistance to mefloquine (MQ), this drug will also be tested. 2. Measure the frequencies of molecular markers for antimalarial drug resistance, and examine how those results relate to the efficacy of these drugs in treating clinical malaria 3. Measure drug levels at 3 days and correlate with efficacy results. 4. Examine early clinical, parasitologic, and clinical predictors of late treatment failure. 5. Use the knowledge gained in Aims 1-3 to develop a molecular tool for a countrywide resistance surveillance system for antimalarial drugs.
NCT00146718 ↗ Anti-Malarial Drug Resistance in Cameroon Completed University of Yaounde Phase 2/Phase 3 2003-08-01 The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Mefloquine Hydrochloride

Condition Name

Condition Name for Mefloquine Hydrochloride
Intervention Trials
Malaria 30
HIV Infections 5
Malaria, Falciparum 3
Pregnancy 3
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Condition MeSH

Condition MeSH for Mefloquine Hydrochloride
Intervention Trials
Malaria 56
Malaria, Falciparum 21
HIV Infections 5
Malaria, Vivax 3
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Clinical Trial Locations for Mefloquine Hydrochloride

Trials by Country

Trials by Country for Mefloquine Hydrochloride
Location Trials
Thailand 12
Myanmar 8
United States 7
Brazil 7
Tanzania 6
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Trials by US State

Trials by US State for Mefloquine Hydrochloride
Location Trials
Maryland 2
Texas 1
New York 1
Missouri 1
Massachusetts 1
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Clinical Trial Progress for Mefloquine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Mefloquine Hydrochloride
Clinical Trial Phase Trials
Phase 4 14
Phase 3 24
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Mefloquine Hydrochloride
Clinical Trial Phase Trials
Completed 43
Terminated 8
Not yet recruiting 7
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Clinical Trial Sponsors for Mefloquine Hydrochloride

Sponsor Name

Sponsor Name for Mefloquine Hydrochloride
Sponsor Trials
University of Oxford 13
Centers for Disease Control and Prevention 8
Medicines for Malaria Venture 6
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Sponsor Type

Sponsor Type for Mefloquine Hydrochloride
Sponsor Trials
Other 166
U.S. Fed 17
Industry 15
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