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Last Updated: January 7, 2025

CLINICAL TRIALS PROFILE FOR ZOVIRAX


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All Clinical Trials for ZOVIRAX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002290 ↗ The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection Completed Glaxo Wellcome N/A 1969-12-31 This double-blind, placebo-controlled study is designed to determine the long-term safety and efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by monitoring the incidence, severity, and time of development of opportunistic infections and other manifestations of advanced symptomatic HIV infection. The effects of the combination and single AZT therapy on immune function and viral replication will also be evaluated. Study participants will be monitored for evidence of toxicity or intolerance to concurrent AZT / ACV administration and AZT therapy alone.
NCT00371592 ↗ Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2) Completed Comprehensive International Program of Research on AIDS Phase 2 2006-09-01 The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time.
NCT00371592 ↗ Effectiveness of Acyclovir in Suppressing HIV Viral Load in Women Coinfected With HIV and Herpes Simplex Virus Type 2 (HSV-2) Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2006-09-01 The purpose of this study is to determine whether acyclovir is effective in suppressing HIV viral load in women infected with both HIV-1 and herpes simplex virus type 2 (HSV-2) who are starting HIV treatment for the first time.
NCT00405821 ↗ Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda Completed Johns Hopkins University Phase 2 2006-11-01 This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2 (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and may make HIV progress faster. The study will evaluate: "Whether people who take acyclovir can avoid antiretroviral treatment until later in their lives "Whether people who take acyclovir get fewer genital ulcers "How well people are able to take acyclovir and any side effects they experience from it "Differences in the amount of HIV virus in the blood of patients who are and are not taking acyclovir, and how HIV/AIDS is different in these patients. People 18 years of age and older living in the Rakai district of Uganda who are infected with both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no active ingredient) daily for 2 years. During this time, they visit the clinic once a month for a routine physical examination. Patients who develop genital ulcers or complications of HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to begin antiretroviral therapy, are treated accordingly.
NCT00405821 ↗ Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda Completed Translational Genomics Research Institute Phase 2 2006-11-01 This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2 (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and may make HIV progress faster. The study will evaluate: "Whether people who take acyclovir can avoid antiretroviral treatment until later in their lives "Whether people who take acyclovir get fewer genital ulcers "How well people are able to take acyclovir and any side effects they experience from it "Differences in the amount of HIV virus in the blood of patients who are and are not taking acyclovir, and how HIV/AIDS is different in these patients. People 18 years of age and older living in the Rakai district of Uganda who are infected with both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no active ingredient) daily for 2 years. During this time, they visit the clinic once a month for a routine physical examination. Patients who develop genital ulcers or complications of HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to begin antiretroviral therapy, are treated accordingly.
NCT00405821 ↗ Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda Completed University of Washington Phase 2 2006-11-01 This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2 (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and may make HIV progress faster. The study will evaluate: "Whether people who take acyclovir can avoid antiretroviral treatment until later in their lives "Whether people who take acyclovir get fewer genital ulcers "How well people are able to take acyclovir and any side effects they experience from it "Differences in the amount of HIV virus in the blood of patients who are and are not taking acyclovir, and how HIV/AIDS is different in these patients. People 18 years of age and older living in the Rakai district of Uganda who are infected with both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no active ingredient) daily for 2 years. During this time, they visit the clinic once a month for a routine physical examination. Patients who develop genital ulcers or complications of HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to begin antiretroviral therapy, are treated accordingly.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ZOVIRAX

Condition Name

Condition Name for ZOVIRAX
Intervention Trials
Herpes Labialis 3
HIV Infections 3
Genital Herpes 1
Stage I Adult Diffuse Large Cell Lymphoma 1
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Condition MeSH

Condition MeSH for ZOVIRAX
Intervention Trials
HIV Infections 4
Herpes Labialis 3
Herpes Simplex 3
Herpes Genitalis 2
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Clinical Trial Locations for ZOVIRAX

Trials by Country

Trials by Country for ZOVIRAX
Location Trials
United States 29
Peru 1
Israel 1
Iran, Islamic Republic of 1
Uganda 1
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Trials by US State

Trials by US State for ZOVIRAX
Location Trials
Florida 3
Texas 2
Illinois 2
California 2
Arizona 2
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Clinical Trial Progress for ZOVIRAX

Clinical Trial Phase

Clinical Trial Phase for ZOVIRAX
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 2
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for ZOVIRAX
Clinical Trial Phase Trials
Completed 8
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for ZOVIRAX

Sponsor Name

Sponsor Name for ZOVIRAX
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 2
University of Washington 2
AiCuris Anti-infective Cures GmbH 1
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Sponsor Type

Sponsor Type for ZOVIRAX
Sponsor Trials
Industry 10
Other 10
NIH 3
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ZOVIRAX Market Analysis and Financial Projection

ZOVIRAX: Clinical Trials, Market Analysis, and Projections

Introduction to ZOVIRAX

ZOVIRAX, the brand name for the antiviral drug acyclovir, has been a cornerstone in the treatment of herpes simplex virus (HSV) infections for decades. Here, we will delve into the current clinical trials, market analysis, and future projections for this pivotal drug.

Clinical Trials and Developments

While ZOVIRAX itself is an established drug, the landscape of antiviral treatments is continually evolving, with new formulations and competitors emerging.

Pritelivir: A New Challenger

Pritelivir, a drug developed by AiCuris, is currently in Phase 3 trials for the treatment of acyclovir-resistant HSV infections in immunocompromised patients. This trial is significant because it aims to address a critical gap where ZOVIRAX may not be effective. The study expects to complete patient enrollment in the first half of 2025 and has shown promising results, including a low risk of drug-drug interactions[1][4].

Ongoing Trials and Comparisons

The trial for pritelivir involves multiple parts, including comparative studies against foscarnet and investigator's choice treatments. These trials are designed to assess the efficacy and safety of pritelivir in subjects with acyclovir-resistant mucocutaneous HSV infections. The results from these trials could potentially impact the market share of ZOVIRAX, especially in cases where acyclovir resistance is a concern[4].

Market Analysis

Current Market Size and Growth

The global acyclovir market, which includes ZOVIRAX, was valued at USD XXX million in 2023 and is expected to grow at a CAGR of XX% from 2025 to 2033. This growth is driven by the rising prevalence of viral infections, increasing awareness about antiviral drugs, and the growing geriatric population[2][5].

Regional Dominance

North America and Europe currently dominate the acyclovir market, accounting for the majority of revenue. However, emerging markets in Asia Pacific and Latin America are expected to witness significant growth due to increasing healthcare spending and improving healthcare infrastructure[2][5].

Key Players

The market is competitive, with key players including GSK, Mylan, TEVA, Zydus Pharmaceuticals, Bausch Health, and others. These companies continue to innovate with new formulations, such as extended-release tablets, which contribute to market growth[2][5].

Market Projections

Future Growth

The global herpes simplex virus treatment market, which includes acyclovir, is projected to grow at a CAGR of 8.1% from 2024 to 2030, reaching a size of USD 2.47 billion by 2030. The acyclovir segment is expected to show the fastest growth due to its widespread acceptance as the gold standard for herpes infection treatment[3].

New Formulations and Approvals

Recent approvals and new product launches, such as Amneal Pharmaceuticals' Acyclovir Cream and Avet Pharmaceuticals' acyclovir capsules, continue to support market growth. These new formulations expand the treatment options available for patients, particularly those with recurrent herpes labialis (cold sores) and genital herpes[3].

Competitive Landscape

Emerging Therapies

While ZOVIRAX remains a dominant player, emerging therapies like pritelivir and other pipeline candidates from companies like AiCuris are poised to challenge its market share. These new drugs target specific needs, such as treating acyclovir-resistant infections and addressing BK virus infections in immunocompromised patients[1].

Combination Therapies

Research into combination antiviral therapies, such as those by Rational Vaccines and Virios Therapeutics, also indicates a potential shift in treatment paradigms. These combination therapies may offer better outcomes for patients with chronic illnesses associated with HSV infections[3].

Conclusion

ZOVIRAX, despite being an established drug, faces a dynamic market landscape. The emergence of new therapies, particularly those targeting acyclovir-resistant infections, and the ongoing innovation in antiviral treatments will continue to shape the market.

Key Takeaways

  • Clinical Trials: Pritelivir is in Phase 3 trials for acyclovir-resistant HSV infections, with promising results.
  • Market Growth: The global acyclovir market is expected to grow significantly, driven by rising viral infections and new formulations.
  • Regional Trends: North America and Europe dominate, but emerging markets are growing rapidly.
  • Competitive Landscape: New therapies and combination treatments are challenging ZOVIRAX's market share.

FAQs

What is the current status of pritelivir in clinical trials?

Pritelivir is currently in Phase 3 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].

How is the global acyclovir market projected to grow?

The global acyclovir market is expected to grow at a CAGR of XX% from 2025 to 2033, driven by rising viral infections and new formulations[2][5].

Which regions dominate the acyclovir market?

North America and Europe currently dominate the acyclovir market, but emerging markets in Asia Pacific and Latin America are expected to grow significantly[2][5].

What are some of the new formulations of acyclovir?

Recent new formulations include extended-release tablets, Acyclovir Cream by Amneal Pharmaceuticals, and acyclovir capsules by Avet Pharmaceuticals[3].

How do emerging therapies impact ZOVIRAX's market share?

Emerging therapies like pritelivir and other pipeline candidates are poised to challenge ZOVIRAX's market share, especially in treating acyclovir-resistant infections and other specific needs[1][3].

Sources

  1. AiCuris Announces Milestone Achievements Further Validating its Pipeline of Anti-viral Solutions for Immuno-compromised Patients. AiCuris.
  2. Acyclovir XX CAGR Growth Outlook 2025-2033. Data Insights Market.
  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. Veeva.
  5. Global Acyclovir Market SWOT Analysis, Dynamics, Drivers, Key Indicators and Forecast to 2020-2025. PharmiWeb.

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