CLINICAL TRIALS PROFILE FOR LEXIVA

All Clinical Trials for Lexiva

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00085943 ↗	KALETRA Or LEXIVA With Ritonavir Combined With EPIVIR And Abacavir In Naive Subjects Over 48 Weeks	Completed	GlaxoSmithKline	Phase 3	2004-05-01	This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed dose combination tablet of abacavir 600 mg and lamivudine 300 mg once a day to suppress virus levels of HIV to less than 400 copies/mL of blood. In addition we will study the safety and tolerability of these compounds over the 48 week study period in patients naive to anti-HIV therapy.
NCT00148785 ↗	A Pharmacokinetic (PK) Study of a Combination of Indinavir, Ritonavir, and Amprenavir	Completed	Emory University	Phase 4	2005-07-01	When individuals who are infected with HIV are started on treatment with HIV medications, the effect of these drugs only lasts for a limited period of time, often because of development of drug resistance by the HIV virus. When this happens, such patients have to be switched to different combinations of HIV medications. However, since the availability of new HIV drugs that are active against resistant virus is limited, HIV care providers are resorting to curtail medications that contain three or more protease inhibitors (PIs). The reason for this is Norvir (ritonavir), a PI that has the ability to boost or increase the blood levels of other PIs in a way that can sometimes overcome the resistance of HIV virus. In addition, it may be more difficult for the virus to overcome two or more drugs with high blood levels, than it is to overcome just one. For these reasons, many clinicians are now using Norvir in combination with two other PIs, including Crixivan (indinavir) plus Lexiva (fosamprenavir), for treating patients who have been exposed to many other HIV medications. While this may be the case, researchers also know that when two or more PIs are combined, the effects each drug may have on the blood level of other drugs could be different. For example, researchers know from some recent studies that the combination of Norvir, Lexiva, and Kaletra, another PI, leads to an unacceptably low level of both Kaletra and Lexiva. Because researchers can not always assume that when multiple HIV medications are combined, the levels will remain high enough to be effective, the investigators think it will always be reasonable that, before any combination of drugs are used on HIV-infected patients, the effect a combination has on the levels of each of the drugs in the combination should be investigated. AIMS: The aim of this pilot study therefore is to examine the blood levels of Crixivan, Lexiva, and Norvir when these three drugs are used together as part of a combination treatment for HIV infection. METHODS: Fifteen (15) HIV-infected volunteers already being treated with a Crixivan and Norvir containing regimen will be recruited from the Grady Infectious Disease Clinic (IDP). Lexiva will be added to this regimen for 5 days, at the end of which participants will be admitted to the Grady General Clinical Research Center (GCRC) where blood samples will be collected at 9 different time points over 12 hours for measurement of blood drug levels. Pharmacokinetic Analysis: The blood concentrations of Crixivan, Lexiva, and Norvir will be measured by a special technique known as reverse-phase high-performance liquid chromatography with ultraviolet detection. Statistical Analysis: The blood level information will be summarized by a statistical method. The researchers will then compare the levels of Lexiva in this combination with historically published levels of Lexiva in a study of Lexiva plus Norvir; and that of Crixivan in a study of Crixivan plus Norvir. A difference of 30% or more in drug levels between this study and historical reports will be considered a significant difference.
NCT00363142 ↗	A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects	Completed	GlaxoSmithKline	Phase 3	2006-05-01	This is a 24-week study to evaluate the efficacy and safety of a once-daily ritonavir-boosted fosamprenavir regimen (1400mg/100mg QD) to a 200mg ritonavir-boosted fosamprenavir regimen administered either twice-daily or once-daily.
NCT00614991 ↗	An Interaction Study to Assess Drug Levels in Healthy Adult Subjects	Completed	GlaxoSmithKline	N/A	2008-01-01	To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL111242 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, HIV-negative adults after administration of a 7-day regimen of RTG 400mg twice a day (BID) alone and after 14-day regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/Ritonavir (RTV) 100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent RTG 400mg BID. Blood samples for drug concentration measurement will be collected over 12 hours at the end of each dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and adherence (by pill count and medication diary) will be assessed by the investigator/study personnel at the end of each dosing period
NCT00614991 ↗	An Interaction Study to Assess Drug Levels in Healthy Adult Subjects	Completed	Garden State Infectious Disease Associates, PA	N/A	2008-01-01	To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir. COL111242 is a randomized, open-label, 6-arm, 3-period, drug interaction study to assess steady-state plasma amprenavir (APV) and raltegravir (RTG) pharmacokinetics in 48 healthy, HIV-negative adults after administration of a 7-day regimen of RTG 400mg twice a day (BID) alone and after 14-day regimens of unboosted fosamprenavir (FPV) 1400mg twice daily (BID), FPV 700mg/Ritonavir (RTV) 100mg BID, or FPV 1400mg/ritonavir (RTV) 100mg once daily (QD) with and without concurrent RTG 400mg BID. Blood samples for drug concentration measurement will be collected over 12 hours at the end of each dosing period. Subjects will undergo a physical examination, complete blood count (CBC) with differential, HIV test, hepatitis B/C test, liver function test, renal function analysis, and lipid panel at screening, and all of these tests, except those for HIV and hepatitis B/C, will be repeated at follow-up post-study. Adverse events and adherence (by pill count and medication diary) will be assessed by the investigator/study personnel at the end of each dosing period
NCT00624195 ↗	Clinical Trial of CNS-targeted HAART (CIT2)	Completed	National Institute of Mental Health (NIMH)	Phase 2/Phase 3	2007-03-01	CIT2 is a strategy for targeting HAART (Highly Active Antiretroviral Therapy) to the CNS (Central Nervous System) in patients with HIV associated neurocognitive impairment (HNCI). The primary goal of this study is to evaluate the effectiveness of CNS-targeted (CNS-T) as compared to non-CNS-targeted (non-CNS-T) HAART in treating HNCI globally and in different domains of functioning known to be affected by HIV. It is hypothesized that participants in the CNS-T arm will have greater improvement in neurocognitive functioning than those in the non-CNS-T arm. The secondary goal of the study is to compare participants assigned to CNS-T and non-CNS-T HAART on measures of CNS and systemic HIV suppression (undetectable CSF and plasma VL). It is also hypothesized that although CSF viral suppression will be more frequent in the CNS-T arm, plasma viral suppression will be similar in the two treatment arms.

Clinical Trial Conditions for Lexiva

Condition Name

Condition Name for Lexiva
Intervention	Trials
Healthy	3
HIV Infection	3
HIV Infections	3
Infection, Human Immunodeficiency Virus	2

Condition MeSH

Condition MeSH for Lexiva
Intervention	Trials
HIV Infections	8
Acquired Immunodeficiency Syndrome	4
Immunologic Deficiency Syndromes	4
Infections	2

Clinical Trial Locations for Lexiva

Trials by Country

Trials by Country for Lexiva
Location	Trials
United States	56
Germany	4
Italy	3
Canada	3
Austria	1

Trials by US State

Trials by US State for Lexiva
Location	Trials
California	5
New York	4
New Jersey	4
Maryland	3
Georgia	3

Clinical Trial Progress for Lexiva

Clinical Trial Phase

Clinical Trial Phase for Lexiva
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Lexiva
Clinical Trial Phase	Trials
Completed	11
Not yet recruiting	1

Clinical Trial Sponsors for Lexiva

Sponsor Name

Sponsor Name for Lexiva
Sponsor	Trials
GlaxoSmithKline	8
Garden State Infectious Disease Associates, PA	3
Felizarta, Franco, M.D.	1

Sponsor Type

Sponsor Type for Lexiva
Sponsor	Trials
Other	11
Industry	9
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Lexiva

Last updated: October 28, 2025

Introduction

Lexiva (generic name: fosamprenavir) is an antiretroviral protease inhibitor primarily used in the treatment of HIV-1 infection. Approved by the U.S. Food and Drug Administration (FDA) in 2003, Lexiva has played a significant role in combination antiretroviral therapy (cART). This article provides a comprehensive update on Lexiva’s clinical trials, analyzes its market landscape, and projects its future trajectory within the global HIV treatment market.

Clinical Trials Update

Historical and Current Clinical Data

Initially, Lexiva was approved based on pivotal Phase II and III trials demonstrating its efficacy and safety in treatment-experienced HIV patients. The drug was shown to significantly reduce viral loads and increase CD4 cell counts with manageable adverse effects [1]. However, subsequent clinical trials have focused on its combination with newer antiretroviral agents and its role in simplified regimens.

Recent and Ongoing Trials

In recent years, Lexiva has been the subject of limited clinical trials due to market shifts favoring newer agents with improved tolerability and dosing convenience. Nevertheless, some notable ongoing studies include:

• Pharmacokinetic and Drug-Interaction Studies: Evaluating Lexiva's performance with novel agents and within different demographic groups.
• The AMBER trial (NCT02961230): Investigating the efficacy of Lexiva in pediatric populations, particularly children with HIV-1 [2].
• Combination Therapy Trials: Assessing Lexiva's compatibility in once-daily regimens with integrase inhibitors like dolutegravir.

Regulatory Status and Formulation Developments

While Lexiva's original formulation required twice-daily dosing, recent reformulations with improved bioavailability aim to target once-daily administration, a goal aligned with current treatment preferences [3]. Regulatory agencies like the FDA and EMA have not issued new labels or approvals since the initial approval, indicating a plateau in development.

Market Analysis

Global HIV/AIDS Treatment Market Overview

The global HIV/AIDS therapeutics market was valued at approximately USD 36 billion in 2022 [4]. As of 2023, antiretroviral drugs constitute a significant share, driven by increasing HIV prevalence and the standardization of lifelong treatment regimens.

Competitive Landscape

Lexiva's primary competitors include newer protease inhibitors (PIs) such as darunavir and atazanavir, which offer improved tolerability and simplified dosing. Additionally, integrase strand transfer inhibitors (INSTIs) like dolutegravir have become first-line therapies, diminishing Lexiva's market share.

Major players include:

• Gilead Sciences: Market leader with drugs like Biktarvy and Descovy.
• ViiV Healthcare: Developer of cabotegravir and dolutegravir.
• Merck & Co.: Supplier of once-daily PIs and other antiretrovirals.

Market Share and Decline of Lexiva

Despite its once-robust market presence, Lexiva’s usage has declined due to several factors:

• Dosing complexity: Twice-daily regimens are less appealing compared to once-daily options.
• Adverse event profile: Higher incidence of lipid abnormalities and gastrointestinal disturbances.
• Emergence of newer agents: Better-tolerated and more convenient drugs.

According to IQVIA data, Lexiva's market share has diminished by over 50% since 2015, predominantly replaced by options like darunavir-based regimens [5].

Regional Market Dynamics

• North America and Europe: Dominated by integrase inhibitors, with minimal Lexiva sales.
• Emerging Markets: Less penetration, often due to cost and clinician preferences, although some regions still prescribe Lexiva in specific cases.

Pricing and Reimbursement

Lexiva's current pricing is considered less competitive compared to generic alternatives and newer agents. Reimbursement policies favor agents with demonstrated superior safety and efficacy profiles, further marginalizing Lexiva’s market potential.

Future Market Projection

Forecast Outlook (2023–2030)

The future of Lexiva hinges on several factors:

• Market Obsolescence: The trend towards simplified, once-daily regimens with better tolerability suggests Lexiva's usage will continue to decline.
• Niche Applications: Potential repositioning for specific patient populations, such as treatment-experienced cases or those with drug resistance, may prolong clinical relevance.
• Patent and Formulation Developments: No current indications of new patents or formulations that could revive its market appeal.

Based on current patterns, Lexiva's global market share is projected to decline further, with annual revenues expected to diminish by approximately 10-15% over the next five years. The drug is likely to become a second- or third-line option, retained in inventory mainly for niche clinical use.

Implications for Stakeholders

Pharmaceutical companies may consider divestment or licensing options rather than direct investments in Lexiva development. Healthcare providers are encouraged to prioritize newer agents with improved profiles, minimizing Lexiva’s role to specialized cases.

Key Takeaways

• Clinical landscape: While Lexiva demonstrated efficacy and safety at approval, recent clinical trials focus mainly on pediatric applications and drug interaction studies, with little evidence of advancement or expansion.
• Market decline: Lexiva’s market share has significantly dwindled due to competitors with better tolerability, simplified dosing, and stronger efficacy profiles.
• Future outlook: The drug's relevance is expected to diminish further, relegating it primarily to niche indications. Market projections indicate continued decline in revenues and usage.
• Strategic emphasis: Stakeholders should prioritize newer antiretroviral agents and consider Lexiva’s role as minimal, mainly for specialized clinical scenarios.

FAQs

Q1: Is Lexiva still approved and used globally?
Yes, Lexiva remains FDA-approved and available in several markets, but its usage has largely waned in favor of more modern therapies.

Q2: Are there ongoing clinical trials for Lexiva?
Current trials are limited, mainly focusing on pediatric applications and pharmacokinetic studies; no major trials are underway exploring novel indications.

Q3: How does Lexiva compare to newer protease inhibitors?
Lexiva generally exhibits less favorable tolerability and convenience—dosing requires twice daily, unlike newer agents like darunavir, which often allow once-daily dosing.

Q4: Can Lexiva be part of a modern HIV treatment regimen?
While possible, it is rarely recommended due to the availability of more effective, tolerable, and convenient options.

Q5: What are the prospects for Lexiva’s future market?
Expect continued decline with potential niche applications; significant development or market expansion prospects are unlikely without reformulation or new indications.

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References

[1] FDA. (2003). FDA approval for Lexiva. U.S. Food and Drug Administration.
[2] ClinicalTrials.gov. (2023). NCT02961230: AMBER trial in pediatric HIV patients.
[3] ViiV Healthcare. (2022). Reformulation updates for Fosamprenavir. Public filings.
[4] MarketsandMarkets. (2022). Global HIV/AIDS therapeutics market report.
[5] IQVIA. (2023). Antiretroviral drug market share reports.