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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR INVIRASE


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All Clinical Trials for Invirase

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002347 ↗ The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection Completed Parexel Phase 2 1969-12-31 To evaluate the tolerance and immunologic and virologic effects of multidrug combinations of antiretrovirals in patients with HIV infection. Specifically, to evaluate zidovudine/zalcitabine ( AZT / ddC ) alone or in combination with either nevirapine or saquinavir ( Ro 31-8959 ). Administration of three-drug combinations for treatment of HIV infection is preferred over monotherapy or duotherapy. A system has been designed to rapidly evaluate current multidrug combinations of antiretrovirals and allow the addition of new agents as they become available.
NCT00051831 ↗ Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Completed AIDS Clinical Trials Group N/A 2003-10-01 HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00051831 ↗ Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 2003-10-01 HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00105079 ↗ GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection Completed Hoffmann-La Roche Phase 3 2005-04-01 This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Invirase

Condition Name

Condition Name for Invirase
Intervention Trials
HIV Infections 12
Directly Observed Therapy 1
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Condition MeSH

Condition MeSH for Invirase
Intervention Trials
HIV Infections 12
Infections 3
Infection 2
Communicable Diseases 1
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Clinical Trial Locations for Invirase

Trials by Country

Trials by Country for Invirase
Location Trials
United States 26
Spain 4
Thailand 4
United Kingdom 3
Puerto Rico 2
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Trials by US State

Trials by US State for Invirase
Location Trials
New York 3
Missouri 3
New Jersey 2
California 2
North Carolina 2
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Clinical Trial Progress for Invirase

Clinical Trial Phase

Clinical Trial Phase for Invirase
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Invirase
Clinical Trial Phase Trials
Completed 11
Withdrawn 1
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Clinical Trial Sponsors for Invirase

Sponsor Name

Sponsor Name for Invirase
Sponsor Trials
Hoffmann-La Roche 5
Roche Pharma AG 2
The HIV Netherlands Australia Thailand Research Collaboration 2
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Sponsor Type

Sponsor Type for Invirase
Sponsor Trials
Other 13
Industry 8
NIH 3
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INVIRASE (Saquinavir Mesylate): Clinical Trials Update, Market Analysis, and Projections

Introduction to INVIRASE

INVIRASE, also known as saquinavir mesylate, is a protease inhibitor used in the treatment of human immunodeficiency virus-1 (HIV-1) infection. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Pediatric Studies

One of the significant clinical trials updates for INVIRASE involves its use in pediatric patients. The pediatric supplemental New Drug Application (sNDA) included data from three studies: PACTG 397, HIVNAT 017, and NV20911. These studies aimed to evaluate the safety, pharmacokinetics (PK), and tolerability of INVIRASE in pediatric patients aged 4 months to 16 years. However, the FDA noted several issues, including unreliable study data and the need for revalidation of the method of analysis, which delayed the approval of this sNDA submission[1].

Combination Therapy

Another notable trial involves the combination of saquinavir with ritonavir (Norvir). This study, conducted by Hoffmann-La Roche, aimed to assess the effectiveness and safety of this combination in both drug-experienced and naive patients with CD4 counts between 100 and 500. The trial highlighted the importance of monitoring toxicity levels and adverse reactions, emphasizing the need for caution until the trial results were known[4].

Safety and Tolerability

Adverse Events

Clinical trials have shown that INVIRASE, when used alone or in combination with other antiretroviral drugs, is generally well-tolerated but can be associated with various adverse events. For example, in the study NV20911, 78% of subjects reported at least one adverse event (AE), with the majority being mild or moderate in intensity. Common AEs included nasopharyngitis, cough, pyrexia, and diarrhea[1].

Serious Adverse Events

More serious adverse events were also reported, including infections and gastrointestinal disorders. In the PACTG 397 study, new Grade 3 and Grade 4 toxicities were experienced by some subjects, although the overall incidence was relatively low[1].

Market Analysis

Global HIV Market

The global HIV market, which includes INVIRASE, is expected to experience modest growth driven by the introduction of novel antiretroviral therapies. However, INVIRASE itself is not anticipated to be a major driver of this growth, given the emergence of newer and more effective treatments. The market is expected to be driven primarily by integrase inhibitor and protease inhibitor-based single-tablet regimens (STRs) from companies like ViiV Healthcare and Gilead[5].

Competitive Landscape

The HIV market is highly competitive, with INVIRASE facing competition from newer protease inhibitors and other classes of antiretroviral drugs. The market share of older protease inhibitors like INVIRASE is expected to decline as newer, more convenient, and potentially more effective treatments become available[5].

Market Projections

Declining Market Share

Given the advancements in HIV treatment and the introduction of newer drugs, the market share of INVIRASE is projected to decline. The global HIV market will be dominated by newer therapies, such as dolutegravir/lamivudine and bictegravir/emtricitabine/tenofovir alafenamide fumarate (TAF), which offer better efficacy and convenience[5].

Limited Growth Opportunities

The growth opportunities for INVIRASE are limited due to its older status in the market and the availability of more advanced treatments. While it may still be used in certain clinical scenarios, its overall market impact is expected to be minimal compared to newer antiretroviral agents.

Key Takeaways

  • INVIRASE has undergone significant clinical trials, particularly in pediatric patients, but faces challenges in approval due to data reliability issues.
  • The drug is generally well-tolerated but can be associated with various adverse events.
  • The global HIV market is expected to grow modestly, driven by newer antiretroviral therapies, but INVIRASE is not anticipated to be a major contributor to this growth.
  • The market share of INVIRASE is projected to decline as newer, more effective treatments become available.

FAQs

What is INVIRASE used for?

INVIRASE (saquinavir mesylate) is used in the treatment of human immunodeficiency virus-1 (HIV-1) infection.

What are the common adverse events associated with INVIRASE?

Common adverse events include nasopharyngitis, cough, pyrexia, and diarrhea, with most being mild or moderate in intensity[1].

Why is the FDA delaying the approval of INVIRASE for pediatric use?

The FDA is delaying approval due to issues with data reliability and the need for revalidation of the method of analysis in the pediatric studies[1].

How does INVIRASE compare to newer HIV treatments?

INVIRASE faces significant competition from newer antiretroviral therapies, which offer better efficacy and convenience, leading to a projected decline in its market share[5].

What are the future market projections for INVIRASE?

The market share of INVIRASE is expected to decline as newer, more effective treatments become available, limiting its growth opportunities in the global HIV market[5].

Sources

  1. FDA: "20628 Saquinavir Clinical PREA - FDA" [PDF].
  2. GlobalData: "NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025".
  3. Fortune Business Insights: "Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032]".
  4. PubMed: "Two protease inhibitors given high expectations - PubMed".
  5. GlobalData: "Global Drug Forecast and Market Analysis to 2025 - GlobalData".

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