CLINICAL TRIALS PROFILE FOR CHLOROQUINE HYDROCHLORIDE
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505(b)(2) Clinical Trials for Chloroquine Hydrochloride
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT05788094 ↗ | DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection | Not yet recruiting | Mahidol Oxford Tropical Medicine Research Unit | Phase 4 | 2023-04-01 | In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria. |
| New Formulation | NCT05788094 ↗ | DHA-PPQ vs CHQ With Tafenoquine for P. Vivax Mono-infection | Not yet recruiting | Shoklo Malaria Research Unit | Phase 4 | 2023-04-01 | In this area of Greater Mekong Subregion (GMS), vivax malaria is the most common kind of malaria. It can stay very long in the liver, and come out later to make another episode of illness. This can happen many times even without a mosquito bite. Only 8-aminoquinoline drugs can kill the liver forms of the malaria parasite. One of these drugs is called primaquine, and it has been used all over the world for a long time. There is now a new formulation of this 8-aminoquinoline drug called tafenoquine that can also treat the malaria in the liver. The main benefit of this drug is that it is a single dose, which makes much convenient for the patients as well as for the malaria control program than conventional 14 days of primaquine. Recent research suggests that ACT (Artemisinin Combination Therapy) may antagonise the efficacy of tafenoquine (Baird et al. 2020) . This could prevent the use of tafenoquine in areas with chloroquine resistant P. vivax parasites where national malaria programmes recommend ACTs for vivax malaria. Also, currently recommended tafenoquine dose is sub-optimal: 300 mg dose proved significantly inferior to low dose primaquine in a meta-analysis of the phase 3 studies when restricted to the Southeast Asian region (Llanos-Cuentas et al. 2019; Watson et al. 2022). A tafenoquine dose of 450mg is predicted to provide >90% of the maximal effect. The objective of this research is to find out whether 450 mg dose of tafenoquine can be combined effectively with ACT providing a short course treatment for P. vivax malaria. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Chloroquine Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00074841 ↗ | Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India | Completed | Pfizer | Phase 2/Phase 3 | 2003-09-01 | This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India. |
| NCT00082563 ↗ | Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum | Terminated | Pfizer | Phase 2 | 2004-08-01 | The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya. |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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Clinical Trial Sponsors for Chloroquine Hydrochloride
Sponsor Name
| Sponsor Name for Chloroquine Hydrochloride | |
| Sponsor | Trials |
| London School of Hygiene and Tropical Medicine | 25 |
| University of Oxford | 19 |
| National Institute of Allergy and Infectious Diseases (NIAID) | 14 |
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