CLINICAL TRIALS PROFILE FOR CYTOVENE

All Clinical Trials for CYTOVENE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	Baylor College of Medicine	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	Icahn School of Medicine at Mount Sinai	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	Johns Hopkins University	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	Memorial Sloan Kettering Cancer Center	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	National Eye Institute (NEI)	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
NCT00000134 ↗	Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)	Completed	New York Presbyterian Hospital	Phase 3	1992-12-01	To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.

Clinical Trial Conditions for CYTOVENE

Condition Name

Condition Name for CYTOVENE
Intervention	Trials
HIV Infections	5
Cytomegalovirus Retinitis	4
Multiple Myeloma and Plasma Cell Neoplasm	1
Myelodysplastic Syndromes	1

Condition MeSH

Condition MeSH for CYTOVENE
Intervention	Trials
Retinitis	5
HIV Infections	5
Cytomegalovirus Retinitis	5
Plasmacytoma	1

Clinical Trial Locations for CYTOVENE

Trials by Country

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−

Trials by Country for CYTOVENE
Location	Trials
United States	36
Canada	1

Trials by US State

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−

Trials by US State for CYTOVENE
Location	Trials
California	4
Washington	2
Pennsylvania	2
Missouri	2
Michigan	2

Clinical Trial Progress for CYTOVENE

Clinical Trial Phase

Clinical Trial Phase for CYTOVENE
Clinical Trial Phase	Trials
Phase 3	3
Phase 2/Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for CYTOVENE
Clinical Trial Phase	Trials
Completed	8
Terminated	1
Recruiting	1

Clinical Trial Sponsors for CYTOVENE

Sponsor Name

Sponsor Name for CYTOVENE
Sponsor	Trials
Johns Hopkins Bloomberg School of Public Health	4
Johns Hopkins University	3
University of Miami	3

Sponsor Type

Sponsor Type for CYTOVENE
Sponsor	Trials
Other	49
NIH	8
Industry	4

Cytomegalovirus (CMV) Treatment: Clinical Trials, Market Analysis, and Projections for CytoVene (Ganciclovir)

Introduction to CMV and CytoVene

Cytomegalovirus (CMV) is a common virus that can cause serious complications, particularly in individuals with weakened immune systems, such as those with HIV/AIDS, organ transplant recipients, and newborns. CytoVene, also known as ganciclovir, is a key antiviral drug used to manage CMV infections.

Clinical Trials Overview

Historical Context: Cytomegalovirus Retinitis Retreatment Trial

One of the significant clinical trials involving ganciclovir was the Cytomegalovirus Retinitis Retreatment Trial. This multicenter trial evaluated three treatments for relapsed CMV retinitis: foscarnet, high-dose ganciclovir, and a combination of foscarnet and ganciclovir. The trial enrolled 279 patients and monitored outcomes such as mortality, retinitis progression, and quality of life. This study highlighted the efficacy and side effects of ganciclovir in treating CMV retinitis[1].

Recent Developments: Maribavir and Comparative Studies

More recent clinical trials have compared ganciclovir with newer antiviral agents like maribavir. The SOLSTICE trial, for example, randomized 352 patients to receive either maribavir or investigator-assigned treatment (IAT) for refractory CMV infections. The results showed that maribavir was superior to IAT in achieving CMV viremia clearance and symptom control, with fewer treatment-emergent adverse events, particularly less acute kidney injury and neutropenia compared to ganciclovir and valganciclovir[4].

Market Analysis

Current Market Size and Growth Projections

The cytomegalovirus treatment market, which includes drugs like ganciclovir, is anticipated to grow significantly. As of 2023, the market was valued at approximately USD 474.6 million and is expected to register a Compound Annual Growth Rate (CAGR) of 6.6% between 2024 and 2032, reaching USD 1,035.16 million by 2032[5][2].

Key Drivers of Market Growth

Several factors are driving the growth of the CMV treatment market:

• Increasing Incidence of CMV Infections: The rising number of immunocompromised individuals, such as organ transplant recipients and those with HIV/AIDS, is a major driver. Improved diagnostic techniques also contribute to higher detection rates[2][5].
• Advancements in Diagnostic Technologies: Enhanced diagnostic methods, including molecular techniques, have improved the detection and management of CMV infections[3].
• Rising Transplantation Activities: The increase in organ and stem cell transplants has led to a higher incidence of CMV infections among recipients, driving the demand for effective treatments[2].

Market Segmentation

The CMV treatment market is segmented based on drug type, application, route of administration, and distribution channel.

• Drug Type: Ganciclovir dominated the market in 2023 with revenue of USD 162.5 million. Other significant drugs include valganciclovir, cidofovir, and foscarnet[5].
• Application: The stem cell transplantation segment held the highest business share of 38.3% in 2023, followed by organ transplantation and congenital CMV infection[5].
• Route of Administration: The intravenous segment is expected to hold the highest revenue throughout the forecast period[5].
• Distribution Channel: Hospital pharmacies dominated the market with revenue of USD 219.9 million in 2023[5].

Challenges and Opportunities

High Cost of Treatment

One of the significant challenges facing the CMV treatment market is the high cost of antiviral drugs, which can impede market growth. However, the development of new and more cost-effective treatments could mitigate this issue[2].

Innovations in Antiviral Therapies

The market is witnessing significant innovations in antiviral therapies. For instance, maribavir has shown promise in treating CMV infections with a different mechanism of action that reduces toxicity and side effects compared to traditional drugs like ganciclovir and valganciclovir[4].

Vaccine Development

Efforts to develop a CMV vaccine are ongoing, with live attenuated vaccines like the Towne strain vaccine showing potential in clinical trials. Successful vaccine development could significantly reduce the prevalence and impact of CMV infections[3].

Key Takeaways

• Clinical Trials: Ganciclovir has been evaluated in various clinical trials, including the Cytomegalovirus Retinitis Retreatment Trial and comparative studies with newer agents like maribavir.
• Market Growth: The CMV treatment market is expected to grow at a CAGR of 6.6% between 2024 and 2032, driven by increasing incidence of CMV infections, advancements in diagnostics, and rising transplantation activities.
• Market Segmentation: The market is segmented by drug type, application, route of administration, and distribution channel, with ganciclovir dominating the drug type segment.
• Challenges and Opportunities: High treatment costs are a challenge, but innovations in antiviral therapies and vaccine development present opportunities for growth.

FAQs

What is the current market size of the CMV treatment market?

The CMV treatment market was valued at approximately USD 474.6 million in 2023[5].

What is the projected growth rate of the CMV treatment market?

The market is expected to register a CAGR of 6.6% between 2024 and 2032[5].

Which drug dominates the CMV treatment market?

Ganciclovir dominated the market in 2023 with revenue of USD 162.5 million[5].

What are the key drivers of the CMV treatment market growth?

Key drivers include the increasing incidence of CMV infections, advancements in diagnostic technologies, and rising transplantation activities[2][3][5].

Are there any new antiviral agents being developed for CMV treatment?

Yes, newer agents like maribavir have shown promise in treating CMV infections with fewer side effects compared to traditional drugs[4].

Sources

1. Design of clinical trials for drug combinations: Cytomegalovirus retinitis. Antiviral Research, Volume 29, Issue 1, January 1996.
2. Cytomegalovirus Treatment Market Size, Share, Global Analysis. Polaris Market Research.
3. Cytomegalovirus Infections Market to Reach a CAGR of 4.32% during 2024-2034. BioSpace.
4. Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant. Clinical Infectious Diseases, Volume 75, Issue 4, 2022.
5. Cytomegalovirus Treatment Market Size – Trends Report, 2032. Global Market Insights.