CLINICAL TRIALS PROFILE FOR ACYCLOVIR

All Clinical Trials for ACYCLOVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000139 ↗	Herpetic Eye Disease Study (HEDS) II	Completed	National Eye Institute (NEI)	Phase 3	1992-10-01	To determine whether early treatment (with oral acyclovir) of herpes simplex virus (HSV) ulcerations of the corneal epithelium prevents progression to the blinding complications of stromal keratitis and iridocyclitis. To determine the efficacy of low-dose oral acyclovir in preventing recurrent HSV eye infection in patients with previous episodes of herpetic eye disease. To determine the role of external factors (such as ultraviolet light or corneal trauma) and behavioral factors (such as life stress) on the induction of ocular recurrences of HSV eye infections and disease.
NCT00000138 ↗	Herpetic Eye Disease Study (HEDS) I	Unknown status	National Eye Institute (NEI)	Phase 3	1989-05-01	To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis in conjunction with topical trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in conjunction with treatment with topical corticosteroids and trifluridine.
NCT00000635 ↗	Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine	Completed	Glaxo Wellcome	N/A	1969-12-31	To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.
NCT00000635 ↗	Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.

Clinical Trial Conditions for ACYCLOVIR

Condition Name

Condition Name for ACYCLOVIR
Intervention	Trials
HIV Infections	27
Herpes Simplex	25
Herpes Labialis	9
Genital Herpes	7

Condition MeSH

Condition MeSH for ACYCLOVIR
Intervention	Trials
Herpes Simplex	42
HIV Infections	30
Infections	23
Infection	22

Clinical Trial Locations for ACYCLOVIR

Trials by Country

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Trials by Country for ACYCLOVIR
Location	Trials
United States	374
Germany	13
Canada	11
Egypt	6
Israel	5

Trials by US State

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Trials by US State for ACYCLOVIR
Location	Trials
California	30
Texas	28
New York	27
Illinois	22
Washington	19

Clinical Trial Progress for ACYCLOVIR

Clinical Trial Phase

Clinical Trial Phase for ACYCLOVIR
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	30
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for ACYCLOVIR
Clinical Trial Phase	Trials
Completed	86
Recruiting	17
Unknown status	9

Clinical Trial Sponsors for ACYCLOVIR

Sponsor Name

Sponsor Name for ACYCLOVIR
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	21
University of Washington	9
Glaxo Wellcome	9

Sponsor Type

Sponsor Type for ACYCLOVIR
Sponsor	Trials
Other	116
Industry	52
NIH	44

Acyclovir: Clinical Trials, Market Analysis, and Projections

Introduction to Acyclovir

Acyclovir is a widely used antiviral medication primarily employed for the treatment and management of herpes simplex virus (HSV) infections, including genital herpes and cold sores. Its effectiveness in reducing the severity and duration of symptoms has made it a cornerstone in the treatment of viral infections.

Clinical Trials Update

Pritelivir: A New Horizon in HSV Treatment

While acyclovir remains the gold standard, emerging alternatives like pritelivir are gaining traction. Pritelivir, developed by AiCuris, is currently in Phase 3 clinical trials for the treatment of acyclovir-resistant HSV infections in immunocompromised patients.

• Trial Design: The clinical trial involves multiple parts, including randomized, open-label, multi-center comparative designs. Parts A and B have been completed, focusing on the efficacy and safety of pritelivir compared to foscarnet in patients with acyclovir-resistant mucocutaneous HSV infections[4].
• Phase 3 Trials: Part C of the trial aims to demonstrate the superiority of pritelivir over investigator's choice in achieving clinical cure rates. The study expects to complete patient enrollment in the first half of 2025[1][4].

Pharmacokinetic Data

Recent pharmacokinetic data published in the journal Clinical Pharmacology in Drug Development highlight that pritelivir has a low risk of drug-drug interactions, which is a significant advantage over traditional antivirals like acyclovir[1].

Market Analysis

Global Market Size and Growth

The global acyclovir market is substantial and growing. Here are some key points:

• Current Market Size: The global acyclovir market size was estimated at USD XX million in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 6.00% from 2024 to 2031[5].
• Regional Dominance: North America dominates the acyclovir market, accounting for over 40% of the global revenue. This is due to the high prevalence of HSV infections and a well-established healthcare infrastructure[5].

Drivers of Market Growth

Several factors are driving the growth of the acyclovir market:

• Increasing Incidence of HSV Infections: The rising prevalence of HSV infections worldwide is a primary driver. HSV infections are highly prevalent, affecting millions globally, and this trend is expected to continue[2][5].
• Growing Awareness and Accessibility: Increasing awareness among healthcare professionals and patients about the benefits of antiviral medications, coupled with improved healthcare infrastructure and government initiatives, is propelling market growth[2][5].

Regional Dynamics

• North America: This region has a robust presence in the acyclovir market due to its advanced healthcare infrastructure and high awareness about sexually transmitted infections[5].
• Asia-Pacific: This region is the fastest-growing market for acyclovir, driven by a large population base, improving healthcare infrastructure, and rising healthcare expenditure[5].

Market Projections

Future Growth

The acyclovir market is projected to continue growing steadily:

• CAGR: The market is expected to grow at a CAGR of 6.00% from 2024 to 2031, with the Asia-Pacific region emerging as the fastest-growing segment[5].
• Segmentation: The market can be segmented based on application, with HSV infections holding the largest share due to their high prevalence[2][5].

Challenges and Opportunities

• Drug Resistance: One of the challenges facing the acyclovir market is the development of drug resistance. However, this also presents an opportunity for new and innovative treatments like pritelivir to fill the gap[2][4].
• New Product Launches: Frequent approvals and new product launches, such as generic versions of acyclovir creams and capsules, are supporting market growth[3].

Key Takeaways

• Clinical Trials: Pritelivir is advancing through Phase 3 trials, offering a promising alternative for acyclovir-resistant HSV infections.
• Market Growth: The global acyclovir market is growing at a CAGR of 6.00% from 2024 to 2031, driven by the rising incidence of HSV infections and improving healthcare infrastructure.
• Regional Dynamics: North America dominates the market, while the Asia-Pacific region is the fastest-growing segment.
• Challenges and Opportunities: Drug resistance is a challenge, but it also opens opportunities for new treatments.

FAQs

What is the current status of pritelivir in clinical trials?

Pritelivir is currently in Phase 3 clinical trials for the treatment of acyclovir-resistant HSV infections in immunocompromised patients, with patient enrollment expected to complete in the first half of 2025[1][4].

What are the primary drivers of the acyclovir market growth?

The primary drivers include the rising incidence of HSV infections, growing awareness and accessibility of antiviral medications, and advancements in pharmaceutical formulations[2][5].

Which region dominates the acyclovir market?

North America dominates the acyclovir market, accounting for over 40% of the global revenue, due to its advanced healthcare infrastructure and high awareness about sexually transmitted infections[5].

What are the challenges facing the acyclovir market?

One of the significant challenges is the development of drug resistance, which reduces the effectiveness of acyclovir and necessitates the development of new treatments[2][4].

What is the projected CAGR for the acyclovir market from 2024 to 2031?

The acyclovir market is expected to grow at a CAGR of 6.00% from 2024 to 2031[5].

Sources

1. AiCuris Announces Milestone Achievements Further Validating its Pipeline of Anti-viral Solutions for Immuno-compromised Patients - AiCuris.
2. North America Acyclovir Market Report 2024 - Cognitive Market Research.
3. Herpes Simplex Virus Treatment Market Size Report, 2030 - Grand View Research.
4. Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir Resistant Mucocutaneous HSV Infections in Immunocompromised Subjects - CenterWatch.
5. Acyclovir Market is Growing at a CAGR of 6.00% from 2024 to 2031 - Cognitive Market Research.