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).

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
Florida	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
Glaxo Wellcome	1

Sponsor Type

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

Last updated: April 27, 2026

CRIXIVAN (indinavir): Clinical-trial status, market analysis, and projection

What is CRIXIVAN and what does it represent in clinical development terms?

CRIXIVAN is the brand name for indinavir, an HIV protease inhibitor marketed by Merck (MSD). As an established antiretroviral with regulatory history and long-market presence, its “clinical trials update” is not driven by new registrational programs in the way newer HIV agents are. Instead, activity centers on label life-cycle, use in specific regimens, and post-marketing/observational evidence aligned to evolving HIV standards of care.

For market analysis and forward projection, indinavir’s practical relevance is tied to:

• the size of the treated HIV population requiring protease inhibitors (PIs),
• the prescribing shift from older PI-based approaches toward integrase strand transfer inhibitors (INSTIs) as preferred backbones,
• and geographic/regimen persistence where older PIs remain in use due to formulary, access, resistance patterns, or cost.

What is the clinical-trial update for indinavir/CRIXIVAN?

Active registrational trials: No current, clearly identifiable ongoing trials for CRIXIVAN/indinavir are positioned as new phase 3 submissions for core indications in major registries in the way typical “trial updates” are tracked for pipeline assets.

What still shows up in clinical evidence for indinavir:

• Studies historically establishing indinavir’s efficacy and resistance profile in combination antiretroviral therapy (ART).
• Post-approval/real-world evidence and regimen evaluation studies.

Interpretation for business planning: CRIXIVAN is best treated as an established product with a mature evidence base rather than a live development program with near-term execution milestones.

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How large is the indinavir/CRIXIVAN market and where does demand come from?

Indinavir’s market reality is shaped by the HIV treatment standard shift toward INSTI-based regimens. That shift reduces new uptake of older PIs in many markets, but does not eliminate use because:

• some patients have prior PI exposure,
• resistance and cross-resistance patterns can favor certain PI classes,
• and payer/formulary mechanisms can keep older therapies available.

Demand drivers

1. Proportion of HIV patients on PI-containing therapy versus INSTI-based regimens.
2. Formulary retention of older PIs in national formularies and payer drug lists.
3. Access pathways where generics of indinavir maintain supply and price competitiveness.

Competitive position

• Indinavir faces competitive pressure from newer PIs with better tolerability and dosing convenience, plus the dominant INSTI category.
• As patents aged and generics expanded, market economics moved toward low-to-moderate value volumes rather than premium pricing.

Regulatory footprint CRIXIVAN’s availability and labeling continue through global pharmaceutical supply channels that now largely rely on generic competition (where indinavir is not fully exclusive).

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What is the patent and exclusivity situation that affects CRIXIVAN economics?

CRIXIVAN is an older small-molecule antiretroviral. As a result, its value is primarily determined by:

• generic market entry (price compression),
• residual brand presence where branded supply persists,
• and local regulatory classifications for generics.

For investment and R&D planning, the key implication is that indinavir is not an R&D-active asset; it is a commercial and lifecycle asset with pricing driven by generic competition rather than patent-driven market power.

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What is the market projection for CRIXIVAN/indinavir over the next 3 to 5 years?

Projection framing (base case):

• Volume: Gradual decline relative to total HIV ART growth due to preference for INSTI-based regimens.
• Price: Continued downward pressure from generics in most markets, with pockets of stability only where formulary access favors retention or where supply is constrained.
• Net revenue: Flat to declining trend in developed markets; more resilience where generic procurement supports ongoing use.

Base-case trajectory (qualitative)

• Year 1: Stable-to-declining revenue as existing patients continue therapy while new starts remain limited by regimen preference.
• Years 2-3: Moderating decline with generics and continued shift to INSTIs.
• Years 4-5: Continued erosion unless a specific access-driven policy or resistance-driven cohort sustains PI use.

Upside / downside

• Upside: Any expansion of PI use driven by resistance patterns, guideline changes in specific regions, or constrained supply that supports pricing.
• Downside: Continued guideline migration toward INSTI regimens, increased generic penetration, and formulary removals.

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What do lifecycle signals indicate for CRIXIVAN now?

Lifecycle signals for older PIs typically include:

• long-term prescription in salvage or PI-experienced populations,
• reduced initiation in treatment-naive patients,
• reliance on generics for bulk demand,
• and label persistence without new efficacy breakthroughs.

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How should R&D and investment teams treat CRIXIVAN commercially?

CRIXIVAN should be treated as:

• a cashflow and formulary-retention subject,
• a benchmark for historical protease inhibitor efficacy and resistance,
• and a comparator for newer PI formulations rather than a growth platform.

If a company is considering PI re-entry or PI class innovation, CRIXIVAN’s commercialization history indicates that incremental value must come from:

• dosing simplification,
• tolerability,
• resistance management,
• or access economics.

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Key Takeaways

• CRIXIVAN (indinavir) is an established HIV protease inhibitor with mature evidence and limited relevance to new registrational trial execution.
• Market demand persists through PI-containing regimen retention, resistance-driven prescribing, and generics-led access, even as INSTI-based regimens dominate new starts.
• Forward projection points to flat-to-declining revenue trends over 3 to 5 years in most settings, driven by generic pricing and reduced initiation.
• The asset is best modeled as a lifecycle/commercial instrument, not an active pipeline growth story.

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FAQs

1. Is CRIXIVAN still being developed in new phase 3 trials?
   No current registrational trial activity is apparent for CRIXIVAN/indinavir as a fresh phase 3 submission program; evidence work is primarily post-approval/real-world.

2. What keeps indinavir sales from collapsing immediately?
   Continued use in patients where PI-based therapy is clinically preferred due to resistance history, regimen constraints, or formulary access, plus generic supply sustaining affordability.

3. How does the rise of INSTI regimens affect indinavir demand?
   It reduces treatment-naive initiation and shifts the growth ceiling to smaller PI-experienced cohorts, compressing long-run volumes.

4. What is the biggest market risk for CRIXIVAN?
   Accelerated formulary removals and deeper generic price competition that reduce net revenue per patient, even if volumes hold.

5. What would create a meaningful upside for indinavir?
   Region-specific access expansions or resistance-driven guideline shifts that increase PI use beyond current baseline, paired with pricing stability.

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References

[1] FDA. CRIXIVAN (indinavir sulfate) prescribing information. U.S. Food and Drug Administration.
[2] EMA. CRIXIVAN (indinavir) product information / assessment history. European Medicines Agency.
[3] ClinicalTrials.gov. Indinavir (and related CRIXIVAN) trial records. U.S. National Library of Medicine.
[4] WHO. Guidelines for antiretroviral therapy (HIV treatment standards and regimen preference). World Health Organization.