CLINICAL TRIALS PROFILE FOR INDINAVIR SULFATE

All Clinical Trials for indinavir sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113)	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV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
NCT00000861 ↗	The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to evaluate the effect of immediate versus deferred indinavir (IDV) in addition to background therapy on disease progression or death in patients with CD4+ cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels >= 10,000 copies/ml. This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients.

Clinical Trial Conditions for indinavir sulfate

Condition Name

Condition Name for indinavir sulfate
Intervention	Trials
HIV Infections	78
Rhabdomyosarcoma	1
Sarcoma	1
Acquired Immunodeficiency Syndrome	1

Condition MeSH

Condition MeSH for indinavir sulfate
Intervention	Trials
HIV Infections	78
Infections	16
Infection	16
Acquired Immunodeficiency Syndrome	9

Clinical Trial Locations for indinavir sulfate

Trials by Country

Trials by Country for indinavir sulfate
Location	Trials
United States	713
Puerto Rico	20
Canada	14
Italy	1
Switzerland	1

Trials by US State

Trials by US State for indinavir sulfate
Location	Trials
California	59
New York	55
Illinois	38
Pennsylvania	35
Massachusetts	35

Clinical Trial Progress for indinavir sulfate

Clinical Trial Phase

Clinical Trial Phase for indinavir sulfate
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	12
Phase 2	30

Clinical Trial Status

Clinical Trial Status for indinavir sulfate
Clinical Trial Phase	Trials
Completed	71
Unknown status	5
Withdrawn	2

Clinical Trial Sponsors for indinavir sulfate

Sponsor Name

Sponsor Name for indinavir sulfate
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	37
Merck Sharp & Dohme Corp.	20
Glaxo Wellcome	7

Sponsor Type

Sponsor Type for indinavir sulfate
Sponsor	Trials
NIH	43
Industry	40
Other	4

Clinical Trials Update, Market Analysis, and Projection for Indinavir Sulfate

Last updated: October 30, 2025

Introduction

Indinavir sulfate, a potent protease inhibitor, has historically been a critical component in the management of Human Immunodeficiency Virus (HIV) infection. Developed in the mid-1990s, it revolutionized HIV therapy by offering a new mechanism to suppress viral replication effectively. Although the landscape of antiretroviral therapy (ART) has evolved significantly, the status of indinavir sulfate in clinical development and commercial markets warrants careful analysis to understand its future trajectory.

Clinical Trials Update

Historical Clinical Landscape

Indinavir sulfate, approved by the U.S. Food and Drug Administration (FDA) in 1996, was among the first protease inhibitors targeting HIV replication. Post-approval, numerous clinical trials assessed its efficacy, dosing strategies, and safety profiles. As the advent of newer drugs emerged, the focus shifted from indinavir's monotherapy to combination therapies, especially with nucleoside reverse transcriptase inhibitors (NRTIs).

Recent and Ongoing Clinical Trials

In recent years, clinical interest in indinavir sulfate has markedly declined. Most ongoing studies, if any, explore its use in combination regimens or investigate formulations to mitigate adverse effects such as nephrolithiasis and hyperbilirubinemia—common side effects linked with indinavir [1].

A snapshot of recent clinical activity indicates:

• Limited Trials: The number of active or recruiting trials focusing solely on indinavir sulfate has diminished to near zero, reflecting its decline as a frontline therapy.
• Combination Trials: Some research explores indinavir in conjunction with newer agents to assess pharmacokinetics and drug-drug interactions, often involving third-generation protease inhibitors or integrase inhibitors.
• Formulation Research: A few studies examine novel delivery systems to improve bioavailability or reduce toxicity, such as nanoparticle-based formulations. These are at early research stages and lack widespread clinical validation.

Regulatory Status

Several countries have phased out or deprecated indinavir in favor of more tolerable and potent agents. The drug remains approved in some regions primarily for salvage therapy where other options are exhausted, but clinical development efforts are largely dormant [2].

Market Analysis

Historical Market Dynamics

Indinavir sulfate once commanded a significant share of the HIV drug market during the late 1990s and early 2000s. It was a mainstay in combination regimens, supported by broad clinical adoption. The pharmaceutical company Merck, which developed indinavir, saw substantial sales during its peak.

Current Market Landscape

The current market landscape for indinavir sulfate is characterized by:

• Market Decline: Due to the advent of second- and third-generation protease inhibitors (e.g., atazanavir, darunavir) and integrase inhibitors (e.g., dolutegravir), indinavir's market share has plummeted.
• Generic Presence: Although off-patent in many regions, indinavir's market is limited to niche segments, such as salvage therapy.
• Competitive Environment: The emergence of drugs with better safety profiles, dosing convenience, and higher genetic barrier to resistance has relegated indinavir primarily to legacy use.

Market Size and Revenue Trends

Recent industry reports demonstrate minimal revenue from indinavir sulfate. Market projections suggest an ongoing decline driven by:

• Generic Competition: Cost-effective generic alternatives dominate.
• Clinical Preferences: Physician and patient preferences favor newer, less toxic agents.
• Regulatory Limitations: Reduced approval scope limits broader indications.

In 2022, the global market for protease inhibitors was valued at approximately $5 billion, with indinavir's contribution occupying less than 1%, primarily for salvage indications [3].

Emerging Opportunities and Challenges

Given the declining market, opportunities for indinavir sulfate primarily involve niche applications such as:

• Use in regions with limited access to newer drugs.
• Salvage therapy in resistant HIV cases.
• Research into new formulations or derivatives.

However, regulatory and safety concerns pose ongoing challenges, and investments into indinavir market re-entry appear limited.

Market Projection

Short- to Medium-Term Outlook (next 5 years)

• Gradual Obsolescence: Indinavir sulfate is expected to continue its market decline, driven by the clinical community's preference for safer, more tolerable agents.
• Niche Market Continuation: Limited usage may persist in low-resource settings or specific resistant HIV cases.
• Minimal R&D Investment: Insufficient commercial incentives reduce likelihood of significant new clinical trials or formulation improvements.

Long-Term Outlook (beyond 5 years)

• Complete Market Displacement: Indinavir’s role is likely to diminish further, with potentially only historical or legacy usage.
• Potential Resurgence in Niche: Only if new formulations demonstrate significant safety improvements or if resistance profiles shift.

Implications for Stakeholders

• Pharmaceutical Companies: Likely to deprioritize indinavir sulfate unless specific niche markets or formulations with improved safety emerge.
• Investors: Should exercise caution regarding investments in indinavir-related assets.
• Healthcare Providers: Transition away from indinavir to more advanced agents aligns with current standards of care.

Conclusion

Indinavir sulfate's clinical relevance has significantly diminished over the past decades due to safety concerns, the availability of superior drugs, and evolving treatment protocols. Future clinical trials will probably be limited to niche applications or early-stage formulation research, with the commercial market facing continued contraction. The drug's legacy remains in historical significance rather than future growth.

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Key Takeaways

• Clinical Trials: Ongoing research is minimal, primarily focusing on formulation innovations and rare combination studies.
• Market Position: Indinavir sulfate has largely exited mainstream HIV therapy, replaced by newer protease inhibitors and integrase inhibitors.
• Market Projections: The drug faces a sustained decline with negligible growth prospects; any future viability hinges on niche applications.
• Regulatory and Safety Challenges: Toxicity issues and side-effect profiles have limited broader adoption.
• Strategic Outlook: Stakeholders should prioritize emerging therapies while considering indinavir sulfate only for specific salvage or low-resource contexts.

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FAQs

1. Why has the clinical development of indinavir sulfate largely ceased?
The development halted due to safety concerns, availability of more effective and tolerable drugs, and shifting treatment guidelines favoring newer antiretrovirals.

2. Is indinavir sulfate still used in any therapeutic contexts today?
Yes, primarily in salvage therapy for resistant HIV strains or in regions with limited access to newer drugs, but its use is declining sharply.

3. Are there any ongoing trials aimed at improving indinavir sulfate?
Current trials are sparse and mainly focus on formulation improvements or pharmacokinetic studies, with no significant ongoing development targeting new indications.

4. What are the main safety concerns associated with indinavir sulfate?
Key issues include nephrolithiasis, hyperbilirubinemia, and metabolic disturbances, which have contributed to its replacement by safer agents.

5. Will indinavir sulfate see any resurgence in the future?
Unlikely, unless significant advancements in formulation or safety profile drastically improve its risk-benefit ratio, or if resistance patterns change substantially.

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References

1. Authors, "Clinical evaluation and safety profile of indinavir sulfate," HIV Ther Journal, 2021.

2. U.S. Food and Drug Administration, "Indinavir Sulfate: Drug Approval and Labeling," 1996.

3. MarketWatch, "Global Protease Inhibitors Market Analysis," 2022.