CLINICAL TRIALS PROFILE FOR ARALEN

All Clinical Trials for Aralen

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00224978 ↗	Chloroquine for Treatment of Glioblastoma Multiforme	Completed	National Institute of Neurology and Neurosurgery, Mexico	Phase 3	2005-01-01	Chloroquine is a strong lysosomotropic and DNA-intercalating agent in experimental studies (Neurosurgical Focus 14(2): February, 2003) and an open-label clinical trial the investigators have demonstrated a strong adjuvant effect of chloroquine on the therapy of malignant gliomas. This study will assess in a randomized, placebo-controlled, double-blind study the effects of chloroquine as adjuvant to the conventional therapy of Glioblastoma Multiforme.
NCT00308620 ↗	Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine	Terminated	Minnesota Medical Foundation	Phase 2/Phase 3	2006-03-01	Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful. This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.
NCT00308620 ↗	Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine	Terminated	University of Minnesota	Phase 2/Phase 3	2006-03-01	Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful. This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.
NCT00308620 ↗	Investigating the Anti-Human Immunodeficiency Virus (HIV) & Anti-inflammatory Effect of Chloroquine	Terminated	University of Minnesota - Clinical and Translational Science Institute	Phase 2/Phase 3	2006-03-01	Summary: Chloroquine is a medication that in laboratory settings has significant anti-HIV effects in HIV infected T-cells. Chloroquine has been used safely for over 60 years for malaria treatment and prevention, and it also has significant anti-inflammatory effects. No formal study of chloroquine has been performed in people with HIV infection. Chloroquine is used worldwide and is quite inexpensive outside of the United States. If shown to be effective, chloroquine could be a very important tool worldwide in delaying HIV disease progression which would extend the time period without needing anti-retroviral therapy. In countries where anti-retroviral therapy is not available, this could be very helpful. This is an 8 week trial study requiring 3 study visits. Participants will be ask to take a once a day study medication (chloroquine or placebo) for 8 weeks and have three blood draws for CD4 counts, HIV viral loads, and other research tests. The visits are at study enrollment, 4 weeks, and 8 weeks.
NCT00323375 ↗	Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1999-08-01	The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic) Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The compound to be studied (AQ-13) is being examined because it is active in vitro against Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials (multi-resistant P. falciparum), and because its safety was similar to that of CQ in preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for study because it is active in vivo in two monkey models of human malaria: 1] P. cynomolgi in the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2] CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with CQ-resistant P. falciparum.
NCT00323375 ↗	Studies of AQ-13, a Candidate Aminoquinoline Antimalarial, in Comparison With Chloroquine	Completed	National Institutes of Health (NIH)	Phase 1	1999-08-01	The purpose of this protocol is to perform Phase 1 (safety/toxicity and pharmacokinetic) Studies of an investigational aminoquinoline antimalarial (AQ-13) in human subjects. The compound to be studied (AQ-13) is being examined because it is active in vitro against Plasmodium falciparum malaria parasites resistant to chloroquine (CQ) and other antimalarials (multi-resistant P. falciparum), and because its safety was similar to that of CQ in preclinical studies performed by SRI International (IND 55,670). AQ-13 was also selected for study because it is active in vivo in two monkey models of human malaria: 1] P. cynomolgi in the rhesus monkey (Macaca mulatta), a model of human infection with P. vivax, and 2] CQ-resistant P. falciparum in the squirrel monkey, a model of human infection with CQ-resistant P. falciparum.

Clinical Trial Conditions for Aralen

Condition Name

Condition Name for Aralen
Intervention	Trials
Malaria	3
Metabolic Syndrome X	1
Glioblastoma Multiforme	1
Multiple Myeloma	1

Condition MeSH

Condition MeSH for Aralen
Intervention	Trials
Malaria	4
Neoplasm Metastasis	1
Metabolic Syndrome	1
Malaria, Falciparum	1

Clinical Trial Locations for Aralen

Trials by Country

Trials by Country for Aralen
Location	Trials
United States	7
Netherlands	2
Mexico	2
Malawi	2
Papua New Guinea	1

Trials by US State

Trials by US State for Aralen
Location	Trials
Ohio	1
New York	1
Connecticut	1
Virginia	1
Missouri	1

Clinical Trial Progress for Aralen

Clinical Trial Phase

Clinical Trial Phase for Aralen
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Aralen
Clinical Trial Phase	Trials
Completed	8
Terminated	3
Enrolling by invitation	1

Clinical Trial Sponsors for Aralen

Sponsor Name

Sponsor Name for Aralen
Sponsor	Trials
University of Maryland, Baltimore	2
National Institute of Allergy and Infectious Diseases (NIAID)	2
LILIA GONZALEZ CERON	1

Sponsor Type

Sponsor Type for Aralen
Sponsor	Trials
Other	26
NIH	4
U.S. Fed	3