CLINICAL TRIALS PROFILE FOR ARALEN

All Clinical Trials for ARALEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for ARALEN

Condition Name

Condition Name for ARALEN
Intervention	Trials
Malaria	3
Malaria,Falciparum	2
Anemia in Children	2

Condition MeSH

Condition MeSH for ARALEN
Intervention	Trials
Malaria	5
Malaria, Falciparum	2
Splenomegaly	1

Clinical Trial Locations for ARALEN

Trials by Country

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Trials by Country for ARALEN
Location	Trials
United States	8
Netherlands	2
Mexico	2
Malawi	2
Papua New Guinea	1

Trials by US State

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−

Trials by US State for ARALEN
Location	Trials
Arizona	1
Ohio	1
New York	1
Connecticut	1
Virginia	1

Clinical Trial Progress for ARALEN

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for ARALEN
Clinical Trial Phase	Trials
Completed	8
Terminated	3
Not yet recruiting	2

Clinical Trial Sponsors for ARALEN

Sponsor Name

Sponsor Name for ARALEN
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
University of Maryland, Baltimore	2
Kamuzu University of Health Sciences	2

Sponsor Type

Sponsor Type for ARALEN
Sponsor	Trials
Other	31
NIH	4
U.S. Fed	3

ARALEN: Clinical Trials, Market Analysis, and Projections

Introduction

ARALEN, also known as chloroquine, is a medication with a long history of use in the treatment of malaria and other conditions. Here, we will delve into the current status of clinical trials, market analysis, and future projections for ARALEN.

Clinical Indications and Usage

ARALEN is indicated for the suppressive treatment and acute attacks of malaria due to various strains of Plasmodium, including P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also used for the treatment of extraintestinal amebiasis[1].

Current Clinical Trials

While ARALEN has been a staple in malaria treatment for decades, recent clinical trials have explored its potential in other areas, particularly in the context of the COVID-19 pandemic.

COVID-19 Treatment Trials

In response to the COVID-19 pandemic, clinical trials have been initiated to evaluate the effectiveness of antimalarial drugs like chloroquine and hydroxychloroquine in treating COVID-19. For example, a clinical trial at Washington University School of Medicine is investigating the use of chloroquine, hydroxychloroquine, and the antibiotic azithromycin in patients hospitalized with COVID-19. These trials aim to determine whether these medications can decrease the severity or duration of respiratory symptoms associated with COVID-19[4].

Market Analysis

Discontinuation of Brand Name

The Aralen brand name has been discontinued in the U.S., but generic versions of chloroquine may still be available and approved by the FDA[1].

Global Malaria Market

The global market for malaria treatments is influenced by various factors, including the prevalence of malaria, resistance to existing drugs, and the development of new treatments. However, specific market projections for ARALEN are not readily available due to its generic status and the discontinuation of the brand name.

Market Projections

Given the generic nature of chloroquine and the lack of brand-specific market data, projections for ARALEN are challenging to pinpoint. However, here are some broader market trends that might influence the use and availability of chloroquine:

Malaria Treatment Market

The market for malaria treatments is expected to evolve with the development of new drugs and the increasing resistance to existing ones. While ARALEN remains effective against certain strains of malaria, its use may be impacted by the emergence of resistant strains and the introduction of newer, more effective treatments.

Impact of COVID-19 Trials

The outcome of clinical trials investigating the use of chloroquine and hydroxychloroquine in COVID-19 treatment could potentially influence the demand for these drugs. However, as of now, these trials are still in the experimental phase, and their impact on the market is speculative.

Challenges and Considerations

Drug Resistance

One of the significant challenges in the use of ARALEN is the development of drug resistance, particularly in the treatment of malaria. This resistance can limit the effectiveness of the drug and necessitate the use of alternative treatments[1].

Geriatric Use

Clinical studies have not adequately addressed the response of elderly patients to ARALEN, but it is known that the drug is substantially excreted by the kidneys. Therefore, elderly patients with impaired renal function may be at a higher risk of toxic reactions[1].

Future Outlook

Regulatory Environment

The future use of ARALEN will be influenced by regulatory approvals and guidelines. For instance, any positive outcomes from COVID-19 trials could lead to expanded use under emergency or regular approvals.

Market Competition

The malaria treatment market is competitive, with various drugs available. The introduction of new treatments and the ongoing development of resistance mechanisms will continue to shape the market landscape.

Key Takeaways

• Clinical Trials: Ongoing trials are exploring the use of chloroquine in COVID-19 treatment, but results are yet to be conclusive.
• Market Analysis: The Aralen brand has been discontinued, but generic versions may still be available.
• Market Projections: The market for malaria treatments is evolving, with new drugs and resistance mechanisms emerging.
• Challenges: Drug resistance and geriatric use considerations are significant factors.
• Future Outlook: Regulatory approvals and market competition will influence the future use of ARALEN.

FAQs

What is ARALEN used for?

ARALEN is used for the suppressive treatment and acute attacks of malaria due to various strains of Plasmodium and for the treatment of extraintestinal amebiasis[1].

Is ARALEN still available in the U.S.?

The Aralen brand name has been discontinued in the U.S., but generic versions of chloroquine may still be available and approved by the FDA[1].

Are there any ongoing clinical trials for ARALEN?

Yes, there are ongoing clinical trials investigating the use of chloroquine and hydroxychloroquine in the treatment of COVID-19[4].

What are the challenges associated with the use of ARALEN?

Challenges include the development of drug resistance and the potential for toxic reactions in elderly patients with impaired renal function[1].

What is the future outlook for ARALEN?

The future use of ARALEN will be influenced by regulatory approvals, market competition, and the outcomes of ongoing clinical trials.

Sources

1. Drugs.com: Aralen: Package Insert / Prescribing Information.
2. GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. PR Newswire: ALK Inhibitors Market: A Comprehensive Overview of Current Trends and Future Projections.
4. Washington University School of Medicine: Clinical trial launches to evaluate antimalarial drugs for COVID-19 treatment.