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.

Clinical Trial Conditions for Amprenavir

Condition Name

Condition Name for Amprenavir
Intervention	Trials
HIV Infections	46
HIV Infection	5
Healthy	5

Condition MeSH

Condition MeSH for Amprenavir
Intervention	Trials
HIV Infections	54
Infections	16
Infection	15

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

Clinical Trials Update, Market Analysis, and Projection for Amprenavir

Last updated: October 28, 2025

Introduction

Amprenavir, an oral protease inhibitor developed by GlaxoSmithKline (GSK), has historically been a vital component in the management of HIV/AIDS. As the landscape of antiretroviral therapy (ART) evolves with new drugs and combination strategies, understanding the current status of Amprenavir from clinical trials, market penetration, and future projections is essential for stakeholders. This report provides a comprehensive update on ongoing clinical trials, analyzes the market landscape, and offers projections based on recent trends and scientific developments.

Clinical Trials Update for Amprenavir

Current Status of Clinical Trials

Although Amprenavir was initially approved by the FDA in 1999, its clinical development has largely transitioned into the post-approval phase, with few new large-scale trials ongoing. Most studies focused on its efficacy, safety, resistance profile, and its use in specific populations, such as pediatric or treatment-experienced patients. The majority of active clinical trials now relate to its pharmacokinetic properties, formulation improvements, and combination efficacy.

• Phase IV and Post-Marketing Surveillance:
  The drug remains under post-marketing surveillance, monitoring long-term safety and resistance in diverse patient cohorts. GSK has not announced new pivotal trials but continues to gather real-world evidence to support its ongoing use.

• Drug Formulation and Delivery:
  Recent studies aim to optimize dosing and reduce pill burden through accelerator formulations, including co-formulations with other antiretrovirals. These efforts seek to improve adherence and minimize adverse effects.

• Drug Resistance and Efficacy:
  Trials evaluate Amprenavir’s efficacy in patients harboring resistant HIV strains, particularly in combination with newer agents to overcome resistance barriers. These include studies assessing its synergy with integrase inhibitors and entry inhibitors.

Notable Clinical Data and Developments

• Resistance profiles:
  Data suggest that Amprenavir retains activity against certain HIV-1 strains resistant to other protease inhibitors, but resistance development remains a concern with prolonged use, emphasizing the importance of combination therapy.

• Safety Profile:
  Long-term safety data highlight gastrointestinal disturbances and lipid profile alterations, common with protease inhibitors. Modifications in formulations have mitigated some adverse effects modestly.

• New Formulation Trials:
  GSK has explored prodrug and nanoparticle formulations to improve pharmacokinetics. These have shown promise but are not yet advanced to late-stage clinical trials.

Regulatory Status

Amprenavir's market presence primarily persists in generic and generic-equivalent formulations. It has not received recent regulatory acceleration or approval for new indications. The drug remains an option in certain multi-drug regimens, with its use declining in favor of newer agents with better tolerability and resistance profiles.

Market Analysis of Amprenavir

Global Market Overview

The market for HIV protease inhibitors has shifted significantly toward newer agents with improved safety and dosing profiles. The global antiretroviral market is projected to grow at a compound annual growth rate (CAGR) of approximately 3-5% over the next five years, driven by increasing HIV prevalence, especially in low- and middle-income countries (LMICs), and expanding access to ART.

• Market Share and Segment Positioning:
  Amprenavir’s share has diminished markedly, primarily confined to generic manufacturers with minimal presence in high-income markets. Its usage is now predominantly in regions where newer drugs are less accessible due to cost or regulatory barriers.

• Pricing and Reimbursement:
  The drug is priced lower in emerging markets; however, reimbursement rates are limited, reducing profitability for manufacturers. In contrast, newer agents like Darunavir and Atazanavir command premium pricing due to superior tolerability and resistance profiles.

• Competitive Landscape:
  The protease inhibitor segment faces stiff competition from integrase strand transfer inhibitors (INSTIs) such as Dolutegravir and Bictegravir, which have become first-line options globally.

Market Drivers and Barriers

• Drivers:

  • Existing infrastructure for Amprenavir-based regimens in LMICs.
  • Cost-effectiveness in generic formulations.
  • Established clinical familiarity among healthcare providers.

• Barriers:

  • Superior safety and tolerability of newer agents.
  • Resistance development reducing long-term efficacy.
  • Limited pipeline for reformulation or new indications.

Future Market Projections

Given current trends, Amprenavir’s market is expected to decline further, approaching niche or off-label use. However, strategic repositioning could involve:

• Generic Market Expansion:
  Continued dominance as a low-cost option in LMICs.

• Combination Therapy Optimization:
  Potential inclusion in fixed-dose combinations with other generics to improve adherence.

• Resistance Management:
  Use in salvage therapy for resistant HIV strains, although newer agents are generally preferred.

Overall, a conservative projection suggests that by 2030, Amprenavir's market share will diminish by over 80%, with annual sales limited primarily to regions with limited access to newer drugs.

Strategic Considerations and Recommendations

1. Pipeline Innovation:
   Investing in advanced formulations such as long-acting injectables or prodrugs could rejuvenate interest and extend clinical utility.

2. Focus on Niche Markets:
   Marketing as part of affordable generic regimens in LMICs or salvage therapies for resistant cases.

3. Regulatory Engagement:
   Pursuing regulatory harmonization to facilitate access in emerging markets.

4. Combination with New agents:
   Evaluating opportunities for minuscule or niche combination products, possibly in fixed-dose forms to improve adherence.

Key Takeaways

• Clinical Trials:
  No recent large-scale Phase III trials are underway. Most ongoing studies focus on pharmacokinetics, formulations, and resistance. The drug remains under post-marketing surveillance, with limited development activity.

• Market Dynamics:
  Amprenavir's market share has significantly declined due to the advent of newer, better-tolerated protease and integrase inhibitors. Its primary presence persists in low-cost generic markets.

• Future Outlook:
  The future of Amprenavir hinges on niche applications, such as salvage therapy or in resource-limited settings, with declining prospects in the blockbuster segment.

• Strategic Positioning:
  To sustain any commercial viability, stakeholders must focus on formulation innovations, strategic partnerships, and expanding access in underserved markets.

Conclusion

Amprenavir exemplifies the lifecycle of early-generation HIV protease inhibitors—initial widespread adoption followed by decline as newer agents dominate. While its clinical development has plateaued, opportunities remain in certain niche markets or innovative formulations. Stakeholders should carefully weigh the diminishing revenue potential against the costs of ongoing development efforts. Aligning strategies with evolving clinical guidelines and market needs will be vital for those seeking to maximize the value of Amprenavir.

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FAQs

Q1: What are the main reasons for the decline in Amprenavir’s market share?
A1: The decline is primarily due to the emergence of newer protease inhibitors and INSTIs with better safety, tolerability, and resistance profiles, making Amprenavir less favorable in standard regimens.

Q2: Are there any ongoing clinical trials exploring new uses for Amprenavir?
A2: Currently, there are no significant ongoing large-scale trials; most research focuses on formulations and resistance monitoring under post-marketing surveillance.

Q3: Can Amprenavir still be effectively used in low-income countries?
A3: Yes. Due to lower costs and existing generic production, it remains an accessible option in resource-constrained settings, though newer agents are gradually replacing it.

Q4: What future developments could extend Amprenavir’s clinical utility?
A4: Innovations like long-acting injectable formulations, nanotechnology upgrades, or combination products could rejuvenate its clinical relevance.

Q5: How does resistance impact the long-term use of Amprenavir?
A5: Resistance development limits its long-term efficacy; combination therapy strategies and resistance monitoring are essential to optimize patient outcomes.

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References

1. [1] FDA Drug Label for Amprenavir (GSK).
2. [2] Market Research Future, "Global HIV Drugs Market Analysis," 2022.
3. [3] World Health Organization, "Guidelines on when to initiate antiretroviral therapy," 2021.
4. [4] GSK Annual Report, 2022.
5. [5] PubMed, "Resistance profiles of Amprenavir in HIV treatment," 2020.