CLINICAL TRIALS PROFILE FOR VIRACEPT

All Clinical Trials for Viracept

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000887 ↗	A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1	1969-12-31	The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
NCT00000887 ↗	A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
NCT00002164 ↗	Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants	Completed	Agouron Pharmaceuticals	Phase 1	1969-12-31	To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.
NCT00002165 ↗	Viracept Expanded Access Program	Completed	Agouron Pharmaceuticals	N/A	1969-12-31	To make nelfinavir mesylate (Viracept) available for treatment of HIV positive patients who are unable to take the three commercially available protease inhibitors (because of failure, intolerance, or contraindication) and who have a CD4 cell count of <= 50. To obtain additional information on the safety profile of nelfinavir mesylate (Viracept). (PER AMENDMENT 1/8/97: People now qualify for the Viracept Program if they are unable to take indinavir and/or ritonavir due to intolerance, contraindication or prior failure.)
NCT00002169 ↗	A Study of Viracept in AIDS Patients With Cytomegalovirus Retinitis	Completed	Agouron Pharmaceuticals	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are already being treated for cytomegalovirus (CMV) retinitis.
NCT00002170 ↗	A Study of Viracept in AIDS Patients With Mycobacterium Avium Complex Disease (MAC)	Completed	Agouron Pharmaceuticals	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give Viracept to AIDS patients who are being treated for MAC.
NCT00002171 ↗	A Study of Viracept in HIV-Positive Women	Completed	Agouron Pharmaceuticals	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give Viracept plus stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count <= 400 cells/mm3. This study also examines how the body handles Viracept when given with d4T and 3TC.

Clinical Trial Conditions for Viracept

Condition Name

Condition Name for Viracept
Intervention	Trials
HIV Infections	21
Stage III Pancreatic Cancer	2
HIV Infection	2
Lymphoma	2

Condition MeSH

Condition MeSH for Viracept
Intervention	Trials
HIV Infections	24
Neoplasms, Plasma Cell	4
Infections	4
Infection	4

Clinical Trial Locations for Viracept

Trials by Country

Trials by Country for Viracept
Location	Trials
United States	132
Spain	6
Canada	6
France	4
Brazil	4

Trials by US State

Trials by US State for Viracept
Location	Trials
California	21
Texas	14
Florida	10
New York	9
Pennsylvania	7

Clinical Trial Progress for Viracept

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Viracept
Clinical Trial Phase	Trials
Completed	28
Terminated	6
Suspended	2

Clinical Trial Sponsors for Viracept

Sponsor Name

Sponsor Name for Viracept
Sponsor	Trials
Agouron Pharmaceuticals	12
National Cancer Institute (NCI)	6
Pfizer	4

Sponsor Type

Sponsor Type for Viracept
Sponsor	Trials
Other	31
Industry	25
NIH	14

Viracept (Nelfinavir Mesylate): Clinical Trials Update, Market Analysis, and Projections

Last updated: January 2, 2025

Introduction to Viracept

Viracept, also known as nelfinavir mesylate, is an antiretroviral drug used in the treatment of HIV-1 infection. It belongs to the class of protease inhibitors, which work by blocking the protease enzyme of the HIV virus, preventing the virus from replicating.

Clinical Trials Update

Efficacy and Safety Studies

Viracept has been extensively evaluated in multiple clinical studies involving both antiretroviral treatment-naïve and experienced adult patients. Here are some key findings:

• Study 511: This study compared the efficacy of Viracept in combination with zidovudine and lamivudine versus zidovudine and lamivudine alone. The results showed that the combination therapy significantly reduced plasma HIV RNA levels, with a higher percentage of patients achieving viral loads below 400 copies/mL[3][4].

• Study ACTG 364 and Avanti 3: These studies further supported the efficacy of Viracept by demonstrating its ability to maintain viral suppression over extended periods. Patients who received Viracept in combination with other antiretroviral drugs showed sustained virologic responses, with many achieving viral loads below 50 copies/mL[3].

• PENTA 7 Study: This open-label study focused on the toxicity, tolerability, and pharmacokinetics of Viracept in young infants. While the study was not specifically designed to evaluate efficacy, it provided valuable data on the safety profile of Viracept in pediatric patients[3].

Long-Term Effects

The anti-HIV effects of Viracept have been shown to persist during long periods of combination therapy. Studies have indicated that when used in combination with other antiretroviral drugs, Viracept can maintain its efficacy over time, contributing to the long-term management of HIV infection[4].

Market Analysis

Global HIV Therapeutics Market

The global human immunodeficiency virus (HIV) therapeutics market is substantial and growing. Here are some key market insights:

• Market Size: The global HIV therapeutics market was valued at USD 39 billion in 2024 and is projected to grow at a CAGR of 3.5% from 2025 to 2034[2].

• Market Share: The market is moderately fragmented, with major players like Gilead Sciences, ViiV Healthcare, and Bristol Myers Squibb holding significant market shares. These companies are known for their innovative products, including Truvada, Dolutegravir, and Isentress[2].

• Regional Growth: The UK, Japan, and Saudi Arabia are expected to see robust growth in their HIV therapeutics markets over the forecast period. This growth is driven by advances in therapeutic treatments, government initiatives, and favorable regulatory approvals[2].

Competitive Landscape

The HIV therapeutics market is competitive, with both established players and new entrants. While Viracept is an older drug, the market continues to evolve with new treatments and formulations:

• New Formulations: The introduction of long-acting injectable drugs like Cabenuva and Apretude is changing the landscape. These drugs offer more convenient treatment options, which are expected to drive market growth[5].

• Generic Drugs: The rise of generic drugs has created a multi-tiered environment, offering lower-cost alternatives and increasing competition in the market[2].

Projections and Future Outlook

Market Growth

The HIV therapeutics market is expected to continue growing, driven by several factors:

• Increasing Incidence: The number of HIV infections is increasing, particularly in certain regions, which will drive the demand for effective treatments[5].

• Advances in Treatment: Ongoing research and the approval of innovative treatments, such as Sunlenca (lenacapavir), are expanding the treatment options available to patients[2].

• Regulatory Support: Favorable regulatory approvals and government initiatives are supporting the growth of the market[2].

Future of Viracept

While Viracept remains an effective treatment for HIV, its market position is likely to be influenced by newer, more convenient treatment options:

• Long-Acting Formulations: The trend towards long-acting injectable drugs and self-administered formulations may reduce the demand for oral medications like Viracept. However, Viracept's established safety and efficacy profile will continue to make it a viable option for certain patients[5].

• Generic Competition: The availability of generic versions of protease inhibitors could impact the sales of branded drugs like Viracept, although its specific niche in the market may help it maintain some market share[2].

Key Takeaways

• Clinical Efficacy: Viracept has demonstrated significant efficacy in clinical trials, particularly when used in combination with other antiretroviral drugs.
• Market Size and Growth: The global HIV therapeutics market is substantial and growing, driven by advances in treatments and increasing incidence of HIV.
• Competitive Landscape: The market is competitive, with new formulations and generic drugs influencing the landscape.
• Future Outlook: While Viracept remains effective, its market position may be impacted by newer, more convenient treatment options.

FAQs

What is Viracept used for?

Viracept (nelfinavir mesylate) is used in the treatment of HIV-1 infection. It is a protease inhibitor that works by blocking the protease enzyme of the HIV virus, preventing the virus from replicating.

What are the key findings from clinical trials of Viracept?

Clinical trials have shown that Viracept, when used in combination with other antiretroviral drugs, significantly reduces plasma HIV RNA levels and maintains viral suppression over extended periods.

How is the global HIV therapeutics market projected to grow?

The global HIV therapeutics market is projected to grow at a CAGR of 3.5% from 2025 to 2034, driven by advances in treatments, increasing incidence of HIV, and favorable regulatory approvals.

Who are the major players in the HIV therapeutics market?

Major players include Gilead Sciences, ViiV Healthcare, and Bristol Myers Squibb, known for their innovative products such as Truvada, Dolutegravir, and Isentress.

How will the introduction of long-acting injectable drugs impact Viracept?

The introduction of long-acting injectable drugs may reduce the demand for oral medications like Viracept, although its established safety and efficacy profile will continue to make it a viable option for certain patients.

Sources

1. Viracept (nelfinavir mesylate) Clinical Studies - Pfizer Medical Information
2. Human Immunodeficiency Virus Therapeutics Market, 2034 - Global Market Insights
3. VIRACEPT (nelfinavir mesylate) Clinical Studies - Pfizer Medical Information
4. Anti-HIV Effects of Viracept Persist During Long Periods of Combination Therapy - Cancer Network
5. SHIONOGI & CO., LTD. - Shionogi Presentation[3][4][5]