CLINICAL TRIALS PROFILE FOR AMPRENAVIR

505(b)(2) Clinical Trials for AMPRENAVIR

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
New Combination	NCT00196625 ↗	Salvage Therapy With Amprenavir, Lopinavir and Ritonavir in HIV-Infected Patients in Virological Failure.	Completed	French National Agency for Research on AIDS and Viral Hepatitis	Phase 2	2000-11-01	HIV infected patients are treated with highly active antiretroviral therapy (HAART). Side effects and the great number of pills reduces adherence to the treatment, and induces therapeutic failure. In order to maintain efficacy of HAART, new combination is evaluated. The aim of the study is to compare the antiviral efficacy of this salvage therapy combining lopinavir and amprenavir with 200 mg/d or 400 mg/d ritonavir, together with nucleoside reverse transcriptase inhibitors, over a 26-week period in HIV-infected patients in whom multiple antiretroviral regimens had failed.

All Clinical Trials for AMPRENAVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000903 ↗	Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To compare time to a virologic failure (first of 2 consecutive plasma HIV RNA levels greater than or equal to 200 copies/ml at or after Week 24) of each 4-drug regimen vs the 3-drug regimen. To determine the safety, tolerance, and virologic benefits of either nelfinavir (NFV) or efavirenz (EFV) with indinavir/lamivudine/zidovudine (IDV/3TC/ZDV) vs IDV/3TC/ZDV alone, in the treatment of patients with advanced HIV disease who have received limited or no prior antiretroviral therapy. Prior ACTG studies have shown that the 3-drug combination regimen (IDV/ZDV/3TC) resulted in improved clinical outcomes and therefore may prolong the effects of therapy. The enhanced effects seen with combination therapies are likely related to a greater suppression of RNA replication and alterations in resistance patterns. Due to the progressive success of combination regimens, it is possible that more potent regimens will further enhance viral suppression and provide more durable treatment responses. In light of the additive suppression of HIV replication determined by pharmacological, immunological, and virological results, nelfinavir (NFV) as an addition to IDV/ZDV/3TC will be evaluated. Based on the potency of nonnucleoside reverse transcriptase inhibitors (NNRTIs) to suppress viral replication and the effectiveness of 3-drug regimens containing NNRTIs, efavirenz (EFV) will also be evaluated as an addition to IDV/ZDV/3TC.
NCT00000912 ↗	A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.
NCT00000918 ↗	A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment. In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.
NCT00000919 ↗	A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to compare the effectiveness of various combinations of anti-HIV drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV). Anti-HIV therapy is effective in preventing the spread of HIV in the body. However, patients often experience unpleasant side effects and have difficulties following the dosing schedule. This study looks for combinations of anti-HIV drugs ("cocktails") which will be the most effective with the fewest problems.
NCT00000940 ↗	Five-Drug Anti-HIV Treatment Followed by Treatment Interruption in Patients Who Have Recently Been Infected With HIV	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1999-05-01	This study will determine what effect taking a combination of five anti-HIV drugs during the early stage of HIV infection, then temporarily stopping them once or twice, may have on the amount of HIV virus in the blood (viral load). The study will also evaluate the safety and effectiveness of this anti-HIV drug combination.
NCT00001085 ↗	A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the proportion of patients whose plasma HIV-1 RNA level remains below a detectable level (less than 500/ml) after 24 weeks of study therapy with either 141W94 monotherapy or 141W94 plus zidovudine (ZDV) and lamivudine (3TC). To determine the safety and tolerability of 141W94 monotherapy and the combination of 141W94 plus 3TC in patients with HIV infection. Although dramatic inhibition of HIV-1 replication is achieved with ritonavir or indinavir monotherapy, in both cases maximum suppression required combination treatment together with nucleoside analog RT inhibitors. This study tests the hypothesis that monotherapy with 141W94 doses that result in Cmin levels far in excess of the IC90 corrected for plasma protein binding for HIV-1 can achieve the same virologic and immunologic effects in terms of magnitude and durability, as has been observed with combinations of other protease inhibitors plus nucleoside analogs.

Clinical Trial Conditions for AMPRENAVIR

Condition Name

Condition Name for AMPRENAVIR
Intervention	Trials
HIV Infections	46
HIV Infection	5
Healthy	5
Infection, Human Immunodeficiency Virus	4

Condition MeSH

Condition MeSH for AMPRENAVIR
Intervention	Trials
HIV Infections	54
Infections	16
Infection	15
Acquired Immunodeficiency Syndrome	13

Clinical Trial Locations for AMPRENAVIR

Trials by Country

Trials by Country for AMPRENAVIR
Location	Trials
United States	354
Canada	12
Puerto Rico	9
France	5
Italy	5

Trials by US State

Trials by US State for AMPRENAVIR
Location	Trials
California	29
New York	28
North Carolina	23
Florida	21
Colorado	17

Clinical Trial Progress for AMPRENAVIR

Clinical Trial Phase

Clinical Trial Phase for AMPRENAVIR
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	7
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for AMPRENAVIR
Clinical Trial Phase	Trials
Completed	57
Unknown status	2
Terminated	2

Clinical Trial Sponsors for AMPRENAVIR

Sponsor Name

Sponsor Name for AMPRENAVIR
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	20
Glaxo Wellcome	18
GlaxoSmithKline	10

Sponsor Type

Sponsor Type for AMPRENAVIR
Sponsor	Trials
Industry	46
NIH	25
Other	18

AMPRENAVIR Market Analysis and Financial Projection

Last updated: April 28, 2026

Amprenavir (APV): Clinical Trial Status Update, Market Dynamics, and Forward Projections

What is Amprenavir and where does it sit in the clinical landscape?

Amprenavir (APV) is an HIV protease inhibitor. In practice, its clinical role is largely historical because it has been superseded in routine use by later regimens and newer protease inhibitors with improved tolerability and dosing convenience. Amprenavir was originally developed and marketed in the early antiretroviral era, and its key clinical evidence base is dominated by pivotal registration studies and subsequent comparative or adjunctive trials performed during that period.

Clinical positioning (high level)

• Indication: HIV-1 infection in combination antiretroviral therapy.
• Drug class: Protease inhibitor (PI).
• Regimen role: Used with ritonavir boosting (typical for PIs) and background NRTIs in clinical practice and studies.
• Current development posture: No active late-stage global program is evident as a continuing brand-new registration pathway; use has migrated toward other PIs and integrase-based regimens across most markets.

Because “clinical trials update” depends on live trial activity, the most decision-relevant point is whether new interventional studies are ongoing. For Amprenavir, the observable pattern in public registries is that the interventional pipeline has largely matured or moved to historical status rather than active, enrollment-driving development for new approvals.

Which trial outcomes define Amprenavir’s evidence base?

Amprenavir’s foundational efficacy and safety profile comes from:

• Registration-era comparative studies vs other protease inhibitors or strategies within combination ART.
• Dosing-optimization studies (including boosting strategies and adherence-focused formulations).
• Long-term safety and resistance-kinetics analyses in heavily treated populations and treatment-naive cohorts.

Those studies established the core clinical properties that later PIs improved upon: virologic suppression in combination ART, typical PI class adverse events (gastrointestinal effects, lipid elevations, lipodystrophy signal management in that era), and resistance patterns driven by protease mutations.

What is the current market structure for Amprenavir?

Amprenavir’s commercial footprint is constrained by:

• Treatment guideline evolution (shift toward newer PI options, integrase inhibitor-based regimens, and once-daily combination products).
• Formulation and dosing friction compared with later PI offerings.
• Competitive crowding from higher-uptake brands and generics that align with current formularies.

Market reality check

• Therapeutic area: HIV antiretroviral therapy.
• Category maturity: Highly mature; most PI-driven treatment algorithms have moved toward newer standards.
• Commercial trajectory: Brand-driven demand has narrowed substantially, and remaining use is usually residual, local, or patient-specific based on tolerability history and physician prescribing patterns.

What pricing and competition factors govern residual demand?

Key market drivers for a legacy PI like amprenavir include:

• Generic penetration: HIV drugs have extensive generic availability in many geographies, which compresses brand economics and makes future “growth” largely dependent on off-formulary niches rather than label expansion.
• Formulary dynamics: Managed care and national formularies favor regimens with lower pill burden and better tolerability evidence.
• Switchability: If patients can switch to better-tolerated or simpler therapies, demand shifts away from legacy PIs.

From a business standpoint, this makes Amprenavir’s market potential less about “new patient starts” and more about:

• continuation of therapy in stable patients when switching risk is high, and
• narrow substitution in constrained settings.

What regulatory and patent posture affects forward projections?

Amprenavir is a known, long-established molecule. For forecasting demand, the decisive economic factor is that long-term exclusivity for the original brand has already passed in most jurisdictions. The practical outcome is that commercial value depends on:

• generic supply stability,
• local procurement contracts,
• and the residual share of patients who remain on PI-based regimens rather than newer classes.

Clinical trial update: what to expect for near-term interventional activity

Given Amprenavir’s maturity, near-term trial activity is expected to be limited to:

• post-marketing observational studies (if any),
• pharmacokinetic or formulation work (less common for legacy molecules),
• and sometimes historical cohort analyses.

The relevant investment and R&D conclusion is that Amprenavir is not a typical candidate for a new global development cycle; its role is mostly as an established PI reference in HIV pharmacotherapy rather than a launch platform.

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Market Analysis and Projection Framework

How should Amprenavir demand be modeled going forward?

For legacy HIV therapeutics, demand typically follows a switching and survivorship model rather than a growth model. A practical projection structure uses:

1. Base continuing population (patients staying on APV due to tolerability, resistance profile, or prior history)
2. New starts (usually minimal where formularies prefer newer regimens)
3. Switch rate (driven by guideline updates, regimen simplification, and adverse effect management)
4. Supply and pricing (generic dynamics influence persistence and substitution patterns)

Projection direction: net decline in most markets unless localized procurement or patient-switch inertia slows the rate.

What are the most likely “market states” for Amprenavir?

For 2026 and beyond, the most realistic states are:

• Stable residual use in certain geographies or subpopulations.
• Slow decline driven by regimen modernization and generic preference.
• Occasional uptick only via constrained switching policies, not via new indications.

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Numbers: What can be projected without speculative inputs?

No credible, decision-grade numerical forecast can be produced here without market volume baselines (patient counts, branded vs generic share, and geography-specific pricing and procurement). This analysis therefore focuses on actionable directional projections and the business levers that determine them.

Directional projection

• Demand trend (global): downward-to-flat over the next 3 to 5 years.
• Market value (revenue): likely declining faster than volume due to generic price compression.
• Share of new starts: approaching minimal in guideline-concordant settings.

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Business Implications for R&D and Investment

Is Amprenavir a viable platform for new development?

Amprenavir is a legacy PI. For investment selection, the molecule typically does not support a stand-alone value thesis unless used as:

• a comparative anchor for PI resistance biology,
• a study comparator in pharmacokinetic or resistance research,
• or part of combination strategy in niche constraints.

If the goal is to build a high-odds program with label-expansion, the molecule’s development runway is structurally limited by:

• established safety and resistance knowledge,
• lack of differentiation opportunity,
• and low likelihood of attracting new regulatory endpoints in a crowded ART ecosystem.

Where does value still exist?

Value can exist in:

• manufacturing scale and generic supply where production cost is favorable and procurement is stable.
• regional procurement persistence where switching is slow.
• therapeutic continuity for patients with resistance patterns or intolerance histories.

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Key Takeaways

• Amprenavir is clinically mature and largely displaced in routine HIV care by newer regimens and improved PI options.
• Clinical trials are mostly historical; near-term interventional activity is not a typical driver for a new development thesis for APV.
• Market demand is residual and switching-driven, not growth-driven, with generic competition compressing revenue.
• Forward outlook: global volume is likely to drift downward or remain flat; value declines are more likely due to generic pricing dynamics.

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FAQs

1) Is Amprenavir still used in current HIV treatment guidelines?

In many settings, routine use is limited because guideline-preferred regimens shifted toward newer classes. APV can persist in residual or patient-specific contexts but is not typically a first-line choice in modern standard algorithms.

2) What is the main reason Amprenavir’s market has shrunk?

Regimen modernization and competitive displacement by newer antiretrovirals plus generic competition. The net effect is reduced new starts and a residual-use profile.

3) What trial outcomes matter most for Amprenavir today?

The historical efficacy and resistance profile established in registration-era combination ART studies and long-term safety observations. Those define its clinical boundaries rather than supporting new label growth.

4) Can Amprenavir see growth in the future?

Growth is unlikely to be driven by new indications or new clinical adoption. Any uptick would come from localized switching constraints, not from broad guideline shifts.

5) What is the best investment lens for Amprenavir now?

Treat it as a legacy supply and residual-demand asset, where value depends on manufacturing economics and procurement stability rather than R&D-led market expansion.

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References

[1] U.S. Food and Drug Administration. Amprenavir drug labeling and regulatory history (access via Drugs@FDA).
[2] National Library of Medicine. ClinicalTrials.gov: Amprenavir (APV) search results and study status listings.
[3] World Health Organization. WHO HIV treatment guideline updates and regimen recommendations (historical revisions reflecting class shifts).
[4] European Medicines Agency. Amprenavir product information and assessment documents (EMEA/EMA archives where applicable).
[5] PubMed. Amprenavir clinical trial publications (registration, comparative, and long-term analyses).