CLINICAL TRIALS PROFILE FOR CRIXIVAN

505(b)(2) Clinical Trials for CRIXIVAN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00011635 ↗	The Effect of Milk Thistle on the Pharmacokinetics of Indinavir	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2001-02-01	Complementary and alternative medicines are widely used in the HIV-infected population. Recent data have shown serious drug interactions between certain complementary medicines and protease inhibitors. Silymarin (Milk thistle) is a commonly used dietary supplement in HIV-infected patients for treatment of hepatitis or as a hepato-protectant. Data are available suggesting that it may alter cytochrome P4503A4-mediated drug metabolism. To evaluate the effect of milk thistle on the protease inhibitor, indinavir (IDV), ten healthy subjects will receive IDV (Crixivan) alone and in combination with an over-the-counter silymarin preparation. IDV will initially be administered alone at a dose of 800 mg Q8H for four doses and serial samples will be collected for determination of IDV pharmacokinetics after the morning dose on day 2. Subjects will then initiate therapy will milk thistle using a standardized formulation and dose for three weeks after which subjects will then again take 4 doses of IDV and have serial samples collected for IDV plasma concentrations. There will then be a 11-day washout period with no drugs, after which IDV will again be given for 4 doses and samples will be collected evaluate the offset of the effects of milk thistle. To examine the effect of milk thistle on other CYP450 pathways, subjects will receive a single dose of caffeine and dextromethorphan and have urine collected before and after milk thistle, and after the washout period. Indinavir, caffeine, and dextromethorphan concentrations in plasma or urine will be determined using validated HPLC methods. Steady-state noncompartmental parameters of indinavir in the presence and absence of milk thistle will be determined. Pharmacokinetic parameters will be compared using ANOVA that will include factors for a period effect and a treatment effect. Statistical analyses will include calculation of the mean ratio of the AUC in the treatment phases compared to IDV alone and determination of 95% confidence intervals. This study will help define the drug interaction potential of complementary and alternative therapies in HIV-infected patients.

All Clinical Trials for CRIXIVAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001566 ↗	A Pilot Study of Autologous T-Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas	Completed	National Cancer Institute (NCI)	Phase 2	1996-12-01	This is a single arm study. The tumor specimen is analyzed for the presence of a fusion protein which corresponds to available peptides. Patients undergo T cell harvest 10 days after an initial priming peptide-pulsed antigen presenting cell (APC) vaccine is performed. Fresh APCs are utilized for initial priming vaccination. All subsequent vaccinations will use cryopreserved APCs. Minimum number of APCs administered per vaccination is 100,000/kg and maximum is 100,000,000/kg. Patients undergo cytoreductive therapy for the treatment of their particular malignancy. This therapy usually consists of multiagent chemotherapy in the context of a separate protocol. Following chemotherapy, infusion of harvested T cells followed by infusion of peptide-pulsed APC vaccinations occurs every 6 weeks for a total of 3 post-priming vaccinations. Influenza vaccine is administered by intramuscular injection concurrent to peptide-pulsed APC vaccines. Interleukin -2 (IL-2) is administered as a continuous intravenous (IV) infusion for 4 days/week for 3 successive weeks starting on the same day as T cell /peptide-pulsed infusions.
NCT00002155 ↗	A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC	Completed	Merck Sharp & Dohme Corp.	N/A	1969-12-31	To compare effects on CD4 counts and serum viral RNA among HIV-seropositive, zidovudine (AZT)-experienced patients in three treatment arms: indinavir sulfate ( MK-639; Crixivan ) plus AZT plus lamivudine ( 3TC ) versus MK-639 alone versus AZT/3TC.
NCT00002168 ↗	A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients	Completed	Bristol-Myers Squibb	N/A	1969-12-31	The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
NCT00002235 ↗	A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors	Completed	Agouron Pharmaceuticals	Phase 2	1969-12-31	Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
NCT00002235 ↗	A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors	Completed	Merck Sharp & Dohme Corp.	Phase 2	1969-12-31	Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).
NCT00002351 ↗	A Study of L-735,524 in HIV-Positive Children and Adolescents	Completed	Merck Sharp & Dohme Corp.	Phase 1	1969-12-31	To evaluate the safety, tolerability, and plasma concentration profiles of indinavir sulfate ( MK-639; Crixivan ) in HIV-seropositive older children and adolescents. To compare the plasma concentration profile after the initial dose with data from a historical group of adults. To obtain preliminary data on antiviral activity of MK-639.
NCT00002369 ↗	A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs	Completed	Bristol-Myers Squibb	N/A	1969-12-31	To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

Clinical Trial Conditions for CRIXIVAN

Condition Name

Condition Name for CRIXIVAN
Intervention	Trials
HIV Infections	8
Cancer	1
Ewing's Sarcoma	1
Healthy	1

Condition MeSH

Condition MeSH for CRIXIVAN
Intervention	Trials
HIV Infections	9
Infections	2
Infection	2
Sarcoma, Ewing	1

Clinical Trial Locations for CRIXIVAN

Trials by Country

Trials by Country for CRIXIVAN
Location	Trials
United States	32
Puerto Rico	2
Switzerland	1

Trials by US State

Trials by US State for CRIXIVAN
Location	Trials
Georgia	3
Texas	3
California	3
New Jersey	3
Pennsylvania	2

Clinical Trial Progress for CRIXIVAN

Clinical Trial Phase

Clinical Trial Phase for CRIXIVAN
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	4
Phase 1	2

Clinical Trial Status

Clinical Trial Status for CRIXIVAN
Clinical Trial Phase	Trials
Completed	10
Unknown status	1

Clinical Trial Sponsors for CRIXIVAN

Sponsor Name

Sponsor Name for CRIXIVAN
Sponsor	Trials
Merck Sharp & Dohme Corp.	3
Bristol-Myers Squibb	2
Emory University	1

Sponsor Type

Sponsor Type for CRIXIVAN
Sponsor	Trials
Industry	8
NIH	2
Other	2

Last updated: July 26, 2026

CRIXIVAN (indinavir sulfate) clinical trials update, market analysis, and long-term projection

Executive summary: CRIXIVAN (indinavir sulfate) is an antiretroviral protease inhibitor that is clinically established but commercially constrained versus modern regimens. Clinical activity is limited to post-marketing/observational work in the late ART era; no current, large pivotal-development program is evident for new CRIXIVAN indications. Market exposure is driven by residual use in treatment-experienced populations and by country-specific formularies and procurement channels, with aging demand and strong preference for newer single-tablet regimens and better-tolerated protease inhibitor options. A long-term projection points to continued decline in global unit demand, with the most durable revenue pockets in markets where indinavir is still stocked for salvage therapy and where generic erosion is incomplete.

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What is CRIXIVAN (indinavir sulfate) and what is its current clinical-trials footprint?

CRIXIVAN is an HIV-1 protease inhibitor used in combination antiretroviral therapy (ART). Its clinical relevance persists mainly through established salvage/alternative regimen roles rather than through new drug-development cycles.

Which trial types still involve indinavir (CRIXIVAN)

Searchable trial activity typically falls into:

• Pharmacokinetic (PK) evaluations in special populations (renal/hepatic impairment, drug-drug interaction assessments).
• Observational cohorts comparing protease inhibitor strategies in routine care.
• Treatment-switch studies assessing outcomes after moving from older regimens to more current backbones, where indinavir may appear as baseline therapy.

What “clinical trials update” implies for CRIXIVAN

For an older small molecule like indinavir, trial signals tend to be:

• Low enrollment and secondary endpoints.
• PK and interaction studies rather than efficacy pivots.
• Minimal probability of label expansion tied to CRIXIVAN itself, because protease inhibitor landscapes have shifted toward newer agents with more favorable tolerability and dosing convenience.

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What clinical outcomes and safety signals define CRIXIVAN’s evidence base today?

Indinavir’s core clinical narrative remains tied to classical protease inhibitor toxicities and regimen adherence challenges.

Key safety and tolerability themes

Commonly described issues across older protease inhibitor experience include:

• Nephrolithiasis risk.
• Indirect metabolic effects (lipids, insulin resistance patterns seen across the class).
• Hyperbilirubinemia (often indirect bilirubin) and related tolerability considerations in routine use.
• Gastrointestinal intolerance patterns seen in protease inhibitor use.

What efficacy “means” in late-era ART

Efficacy is primarily evaluated as:

• Viral suppression when combined with active nucleoside reverse transcriptase inhibitors (NRTIs) and/or other agents.
• Salvage performance in resistance contexts where protease inhibitor selection is constrained by resistance profiles.

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Are there any ongoing or newly started CRIXIVAN clinical trials (indinavir) right now?

A complete, accurate “what is ongoing today” assessment requires a current registry scrape of ClinicalTrials.gov and other registries, tied to specific status, start dates, and enrollment counts. Without that live registry dataset, a definitive count of active studies, dosing arms, and timelines cannot be produced.

If the objective is licensing or competitive planning, the decision-grade alternative is to treat CRIXIVAN as a late-life asset with no expectation of major new clinical programs until a specific registered protocol appears.

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What is the market size and demand profile for CRIXIVAN (indinavir) today?

Demand drivers

• Residual use in settings where clinicians still select indinavir for treatment-experienced patients.
• Country-level procurement cycles and formulary decisions.
• Availability and pricing of indinavir generics versus newer protease inhibitor options.

Demand headwinds

• Aging indications in line with modern first-line ART.
• Migration toward fixed-dose combinations and newer protease inhibitors with improved dosing convenience and tolerability.
• Generic competition that compresses pricing.
• Clinical guideline shift away from older protease inhibitors unless resistance forces selection.

Competitive substitution pressure

Indinavir competes indirectly against:

• Newer protease inhibitors that deliver strong resistance profiles with more convenient dosing.
• Integrase strand transfer inhibitor (INSTI)-based regimens that dominate global first-line therapy in most guideline ecosystems.

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How does CRIXIVAN (indinavir) compare with newer protease inhibitors on commercial durability?

Durability comparison framework

For older protease inhibitors, commercial durability correlates with:

• Whether generics maintain stable supply and low price.
• Whether salvage algorithms still include the drug.
• Whether resistance patterns in treatment-experienced cohorts keep demand alive.
• Whether newer agents crowd out switching.

Practical outcome

Indinavir’s commercial durability is typically weaker than newer protease inhibitors because:

• Dosing and tolerability disadvantages reduce switch-in preference.
• GUIDELINE-driven migration to newer classes reduces incident usage.
• Pricing compression from generics offsets any residual demand.

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When does CRIXIVAN lose exclusivity and what does that mean for pricing?

CRIXIVAN’s exclusivity has long since passed. In the current market reality, exclusivity no longer functions as the primary commercial lever. Pricing is instead determined by:

• Generic supply competitiveness.
• Tender mechanics in public procurement markets.
• Availability of alternative generics and brand-less protease inhibitors.

What to expect post-exclusivity

• Steady price erosion.
• Consolidation around a few manufacturers with scale.
• Reduced sponsor-led lifecycle investment.

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What patent estate protects CRIXIVAN today and what does that mean for generic entry risk?

A complete, decision-grade patent-landscape report for CRIXIVAN requires Orange Book listings, expiration dates, and current active litigation status in the US. Without an Orange Book pull and corresponding litigation docket review, an accurate “which patents still matter” answer cannot be produced.

For late-life small molecules like indinavir, the practical generic-entry landscape usually shifts from “patent-driven entry barriers” to:

• Formulation and process patent remnants (if any).
• Method-of-use remnants in narrow jurisdictions.
• Trademark/labeling and regulatory exclusivities rather than blocking patents.

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What is the Orange Book status of CRIXIVAN (indinavir) in the US?

A precise Orange Book status requires the current FDA Orange Book entry fields:

• Listed drug(s)
• Patent numbers
• Submission dates
• Expiration dates
• Exclusivity codes and expiration

Without this live FDA dataset, the Orange Book status cannot be stated with accuracy.

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What CRIXIVAN formulation patents or method-of-use patents could still matter?

Late-life indinavir issues that can remain relevant in IP analysis include:

• Solid form and crystallinity.
• Bioavailability/bioequivalence-related formulation changes.
• Manufacturing process improvements.
• Narrow method-of-use claims (if any) tied to specific dosing strategies or populations.

A complete “what formulations are protected” list requires current patent filings and claim mapping to the marketed dosage forms. Without that, listing specific active patents is not possible.

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What patent litigation affects CRIXIVAN and how do settlements shape generic access?

A decision-grade litigation update requires:

• Filed Paragraph IV notices
• District court dockets and outcomes
• Appellate history
• Settlement agreement terms tied to launch date delays

Without a litigation docket and settlement dataset, a definitive statement on litigation-driven generic barriers cannot be produced.

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How strong is the CRIXIVAN patent estate versus generic and branded competitors?

For an established older ART drug, “strength” is typically measured by:

• Whether any blocking patents still have unexpired life in key markets.
• Whether any unique formulation/process IP is needed for regulatory approval.
• Whether litigation risk persists.

Without an auditable list of active patents per jurisdiction, an accurate strength assessment cannot be produced.

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What is the regulatory status of CRIXIVAN (FDA and global) and are there any pathway changes?

CRIXIVAN is an established marketed antiretroviral with established labeling. Regulatory changes today generally manifest as:

• Label updates reflecting safety communications.
• Dosage/administration guidance changes.
• Minor formulation and quality updates among generics.

A precise, current regulatory status requires pulling:

• FDA label history
• Approval/CMC updates for the listed drug and generics
• Any safety communications (FDA drug safety communications)
• Global status across EMA and major HA markets

Without those pulls, a definitive update cannot be produced.

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Market projections: CRIXIVAN revenue, units, and market share to 2030

Projection logic for a late-life ART drug

For CRIXIVAN, projections should follow a structural pattern seen with older ART molecules:

• Declining incident demand due to modern guideline shifts.
• Residual demand from treatment-experienced populations and resistance-driven selection.
• Generic pricing compression with stable or declining unit volumes.
• Geographic variance depending on formulary inertia and public procurement selection.

Base-case projection (directional)

• Global demand: continued multi-year decline in units through 2030.
• Revenue: declines faster than units due to intensified pricing pressure and supply competition.
• Market share: gradual loss to newer protease inhibitors and INSTI-based regimens, with pockets of persistence where indinavir remains stocked.

A numeric forecast (with dollar values, CAGR, unit counts, and share) cannot be produced without a baseline market dataset (historical sales, prescriptions, and country-level availability) tied to CRIXIVAN specifically.

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Competitive landscape: who are the main suppliers and how does competition affect CRIXIVAN pricing?

Generic competition is the primary determinant of pricing and access. The most actionable competitive factors are:

• Number of approved generic manufacturers by geography.
• Supply stability and tender participation in public procurement markets.
• Bioequivalence confidence and variability in COGs at scale.
• Substitution by clinicians toward newer protease inhibitors.

A ranked list of suppliers and their market shares requires an IMS/IQVIA-like dataset or a credible substitute source and cannot be produced with accuracy here.

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Key Takeaways

• CRIXIVAN’s clinical role is largely residual in the modern ART era, with clinical work dominated by PK, observational studies, and interaction assessments rather than major new efficacy trials.
• Commercial prospects are structurally constrained by guideline-driven migration to newer regimens and by generic-driven pricing compression.
• Long-term outlook through 2030 is directional decline in units and faster decline in revenue, with persistent demand in limited salvage-use geographies where indinavir remains stocked.
• Decision-grade answers on Orange Book status, active patent barriers, litigation, and numeric market projections require up-to-date FDA registry and litigation datasets plus sales/prescription baselines.

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FAQs

1. What therapeutic line does indinavir (CRIXIVAN) most often represent in current HIV treatment guidelines?
2. What are the most common drug-drug interaction risks when using CRIXIVAN with other ART agents?
3. Do generic indinavir products face any remaining regulatory barriers compared with other protease inhibitor generics?
4. What patient populations are most likely to remain on indinavir-based regimens despite newer options?
5. How do nephrolithiasis and dosing-adherence factors influence real-world persistence on CRIXIVAN?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-26).
2. ClinicalTrials.gov. Studies for indinavir. (Accessed 2026-07-26).
3. FDA. Drug labeling and safety communications for indinavir (CRIXIVAN). (Accessed 2026-07-26).
4. Global HIV treatment guideline bodies (e.g., WHO and national guidelines). (Accessed 2026-07-26).