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Last Updated: January 6, 2025

CLINICAL TRIALS PROFILE FOR INDINAVIR SULFATE


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All Clinical Trials for INDINAVIR SULFATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00000804 ↗ A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113) Withdrawn National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV protease enzyme. It will be used with interleukin-2 in patients infected with HIV.
NCT00000841 ↗ A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
NCT00000848 ↗ The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.
NCT00000850 ↗ The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 The purpose of this study is to see how HIV-positive patients who are taking anti-HIV drugs and have a viral load (level of HIV in the blood) of 1,500 copies/ml or more respond to GM-CSF (granulocyte-macrophage colony-stimulating factor). GM-CSF is a medication that is being tested in HIV-positive patients to see if it can improve their immune systems or if it can lower the level of HIV in their blood. GM-CSF is often given to patients with leukemia or patients who have received bone marrow transplants to increase their white blood cells and to improve their immune systems. Doctors believe that GM-CSF can increase CD4 counts in HIV-positive patients, but this study will also look at how GM-CSF affects viral load.
NCT00000859 ↗ A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3 Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 [AS PER AMENDMENT 3/11/98: less than or equal to 200 cells/mm3]. To compare NFV with RTV for the development of adverse events and for rates of permanent discontinuation of study medication. [AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease progression, including death, the following two regimens: NFV plus background combination antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant intolerance.] [AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD4+ cell counts <= 200/mm3 who are enrolled in protocol CPCRA 042.] AR therapy is rapidly becoming the standard of care for the treatment of HIV infection. AR therapy provides the best opportunity for maximizing viral suppression, reducing toxicity and delaying the emergence of resistant strains. The newest class of AR agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a population with advanced HIV disease, who are taking various background nucleoside therapies.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for INDINAVIR SULFATE

Condition Name

78001020304050607080HIV InfectionsEwing's SarcomaHemophilia AHypertension[disabled in preview]
Condition Name for INDINAVIR SULFATE
Intervention Trials
HIV Infections 78
Ewing's Sarcoma 1
Hemophilia A 1
Hypertension 1
[disabled in preview] 0
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Condition MeSH

7816169001020304050607080HIV InfectionsInfectionsInfectionAcquired Immunodeficiency Syndrome[disabled in preview]
Condition MeSH for INDINAVIR SULFATE
Intervention Trials
HIV Infections 78
Infections 16
Infection 16
Acquired Immunodeficiency Syndrome 9
[disabled in preview] 0
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Clinical Trial Locations for INDINAVIR SULFATE

Trials by Country

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Trials by Country for INDINAVIR SULFATE
Location Trials
United States 713
Puerto Rico 20
Canada 14
Italy 1
Switzerland 1
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Trials by US State

+
Trials by US State for INDINAVIR SULFATE
Location Trials
California 59
New York 55
Illinois 38
Pennsylvania 35
Massachusetts 35
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Clinical Trial Progress for INDINAVIR SULFATE

Clinical Trial Phase

5.6%22.2%55.6%16.7%051015202530Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for INDINAVIR SULFATE
Clinical Trial Phase Trials
Phase 4 3
Phase 3 12
Phase 2 30
[disabled in preview] 9
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Clinical Trial Status

87.7%6.2%0010203040506070CompletedUnknown statusTerminated[disabled in preview]
Clinical Trial Status for INDINAVIR SULFATE
Clinical Trial Phase Trials
Completed 71
Unknown status 5
Terminated 2
[disabled in preview] 3
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Clinical Trial Sponsors for INDINAVIR SULFATE

Sponsor Name

trials0510152025303540National Institute of Allergy and Infectious Diseases (NIAID)Merck Sharp & Dohme Corp.Glaxo Wellcome[disabled in preview]
Sponsor Name for INDINAVIR SULFATE
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 37
Merck Sharp & Dohme Corp. 20
Glaxo Wellcome 7
[disabled in preview] 6
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Sponsor Type

49.4%46.0%0051015202530354045NIHIndustryOther[disabled in preview]
Sponsor Type for INDINAVIR SULFATE
Sponsor Trials
NIH 43
Industry 40
Other 4
[disabled in preview] 0
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INDINAVIR SULFATE Market Analysis and Financial Projection

Indinavir Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction to Indinavir Sulfate

Indinavir sulfate is a potent and selective HIV protease inhibitor, widely used in the treatment of HIV-1 and HIV-2 infections. Its chemical name is 2,3,5-Trideoxy-N-[(1S,2R)-2,3-dihydro-2-hydroxy-1H-inden-1-yl]-5-[(2S)-2-[[(1,1-dimethylethyl)amino]carbonyl]-4-(3-pyridinylmethyl)-1-piperazinyl]-2-(phenylmethyl)-D-erythro-pentonamide sulfate[1].

Clinical Trials and Efficacy

HIV Treatment

Indinavir sulfate has been extensively studied for its efficacy in treating HIV infections. It inhibits the protease enzyme of HIV, preventing the virus from replicating. Clinical trials have shown that indinavir sulfate is effective in reducing the viral load in HIV-infected patients. For instance, it stops the spread of HIV-infected MT4 lymphoid cells at concentrations of 25-50 nM[1].

Combination Therapy

Recent studies have explored the use of indinavir sulfate in combination with other antiretroviral therapies. While not directly related to indinavir, the approach of combining antiretrovirals is exemplified by Merck's trials on doravirine/islatravir, which highlight the efficacy of combination therapies in maintaining virological suppression[3].

Kaposi Sarcoma Treatment

A significant clinical trial has demonstrated the efficacy of indinavir sulfate in treating advanced classic Kaposi sarcoma (CKS) when combined with debulking chemotherapy. This phase 2 trial showed that indinavir sulfate can boost and extend the effects of chemotherapy, leading to high and durable response rates without additional toxicity. The overall response rate at the end of the maintenance phase was 75%, with a median response duration of 43 months[4].

Market Analysis

Current Market Size and Growth

The global indinavir sulfate market has witnessed substantial growth in recent years. As of 2023, the market size is anticipated to continue its upward trajectory, with projections indicating significant expansion from 2023 to 2031. The market is segmented based on type (tablet, capsule) and application (hospital, pharmacy), as well as geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2].

Market Dynamics

The market dynamics are influenced by several factors, including drivers, restraints, opportunities, and challenges. Key drivers include the increasing prevalence of HIV infections and the need for effective antiretroviral therapies. Restraints may include the emergence of drug-resistant strains and the high cost of treatment. Opportunities lie in the development of combination therapies and the expansion into new geographical markets[2].

Regional Analysis

The market analysis covers various geographical regions, providing insights into supply, demand, and competition. For instance, the report details the historical and current market trends in North America, South America, Asia-Pacific, Europe, and the Middle East and Africa. This segmentation helps in understanding the regional demand and supply dynamics, as well as the competitive landscape[5].

Market Projections

Forecasted Growth

The indinavir sulfate market is expected to grow significantly from 2023 to 2031. The forecast includes detailed analyses of supply and demand, competition among players, and type segmentation. The market is anticipated to reach a substantial value by the end of 2031, driven by the increasing demand for effective HIV treatments and the potential for new applications such as in the treatment of Kaposi sarcoma[2].

Emerging Trends

Emerging trends in the market include the development of new formulations and the potential use of indinavir sulfate in combination with other therapies. The market is also expected to be influenced by regulatory changes, technological advancements, and shifts in consumer behavior. For example, in silico docking models suggest potential as an inhibitor of SARS-CoV-2 3CLpro, which could open new avenues for research and application[1].

Key Players and Competition

The global indinavir sulfate market is characterized by the presence of several key players, both major and minor. These companies are involved in the production, distribution, and marketing of indinavir sulfate. The report provides a detailed analysis of the competitive landscape, including SWOT analyses of major players and their market share in different regions[5].

Conclusion

Indinavir sulfate remains a crucial component in the treatment of HIV infections, with a strong clinical efficacy profile and a growing market presence. The combination of its antiretroviral properties and potential applications in treating other conditions like Kaposi sarcoma positions it for continued growth and relevance in the pharmaceutical market.

Key Takeaways

  • Clinical Efficacy: Indinavir sulfate is a potent HIV protease inhibitor effective in treating HIV-1 and HIV-2 infections.
  • Combination Therapy: It shows promise when used in combination with other antiretroviral therapies.
  • Kaposi Sarcoma: It is effective in treating advanced classic Kaposi sarcoma when combined with chemotherapy.
  • Market Growth: The global market is expected to grow significantly from 2023 to 2031.
  • Regional Analysis: The market is segmented by type, application, and geographical regions.
  • Emerging Trends: Potential new applications and technological advancements are expected to influence market dynamics.

FAQs

What is indinavir sulfate used for?

Indinavir sulfate is primarily used as an HIV protease inhibitor to treat HIV-1 and HIV-2 infections.

How effective is indinavir sulfate in treating HIV?

Indinavir sulfate is highly effective in reducing the viral load in HIV-infected patients, with Ki values of 0.52 and 3.3 nM for HIV-1 and HIV-2, respectively[1].

Can indinavir sulfate be used to treat other conditions?

Yes, it has shown efficacy in treating advanced classic Kaposi sarcoma when combined with debulking chemotherapy[4].

What is the current market size of indinavir sulfate?

The current market size and specific values are not provided, but the market is anticipated to grow significantly from 2023 to 2031[2].

Who are the key players in the indinavir sulfate market?

The report includes global key players of indinavir sulfate, but specific names are not mentioned in the provided sources[5].

Sources

  1. R&D Systems: Indinavir sulfate | HIV Protease Inhibitors.
  2. Market Research Intellect: Global Indinavir Sulfate Market Size, Scope And Forecast Report.
  3. Merck: Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults with Virologically Suppressed HIV-1 Infection.
  4. PubMed: Clinical Efficacy of the HIV Protease Inhibitor Indinavir in Elderly with Advanced Classic Kaposi Sarcoma.
  5. Market Publishers: 2018 Global Indinavir sulfate (CAS 157810-81-6) Industry Report - History, Present and Future.

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