CLINICAL TRIALS PROFILE FOR LEXIVA

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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.
NCT00624195 ↗	Clinical Trial of CNS-targeted HAART (CIT2)	Completed	National Institutes of Health (NIH)	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
Immunologic Deficiency Syndromes	4
Acquired Immunodeficiency Syndrome	4
Infection	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
France	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
National Institutes of Health (NIH)	1

Sponsor Type

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

Last updated: July 28, 2026

Lexiva (fosamprenavir): clinical trials update, market analysis, and launch-cost projections

Lexiva is the brand name for fosamprenavir, an oral HIV-1 protease inhibitor (PI) marketed by GlaxoSmithKline (GSK). For business planning, the key point is that Lexiva is a long-cycle, mature product with limited visibility for new interventional trials and constrained market growth due to entrenched competitor PIs and integrase-based regimens. The economic profile is dominated by (1) remaining patent and regulatory exclusivity status in relevant markets, (2) generic erosion in regions where fosamprenavir tablets are off-patent, and (3) residual use driven by treatment-experienced patients and regimen-specific tolerability.

No complete, accurate clinical-trials update and current market-projection dataset can be produced from the information available in this chat.

What clinical trials updates exist for Lexiva (fosamprenavir) in 2024–2026?

A complete, auditable update requires an up-to-date registry pull (ClinicalTrials.gov and EU CTR), including trial phase, status changes, enrollment, endpoints, and dates. Those data are not provided here, and without them the result would be incomplete.

What phases and endpoints are most relevant for fosamprenavir trials?

Key trial types, where they exist historically for this class and molecule, typically include:

• Treatment-experienced PI switch or simplification studies
• Comparative tolerability and virologic suppression endpoints (HIV-1 RNA <50 copies/mL)
• Resistance-associated mutation (RAM) response and pharmacokinetic (PK) bridging in special populations

A trials update cannot be stated without current registry facts.

How big is the global Lexiva (fosamprenavir) market and what is the category outlook?

Market sizing and projections require:

• current and historical sales (e.g., IQVIA/GlobalData), by geography and dosage form
• competitor mix within HIV ART, especially PI vs integrase inhibitor shares
• pricing and generic penetration rates

These datasets are not present in this chat, so a precise projection cannot be produced.

Where does Lexiva sit versus modern HIV regimens?

Commercially, fosamprenavir faces structural headwinds:

• Integrase inhibitors drive first-line guideline preference and high uptake
• PI use shifts toward specific patients with prior regimen constraints or resistance patterns
• Generic competition in many markets compresses price and reduces brand value

A quantifiable assessment needs current market share and unit volume.

When does Lexiva lose exclusivity and how many patents cover fosamprenavir?

This requires an Orange Book and/or international patent landscape dataset for fosamprenavir, including:

• US NDA/BLA listing(s) for Lexiva (strengths and dosage forms)
• patent numbers, listed expirations, and pediatric exclusivity where applicable
• method-of-use and formulation patents
• harmonized filings in key jurisdictions (EU, UK, JP, CA, AU, BR, MX, etc.)

No such patent-listing facts are provided here, so the exclusivity and “how many patents cover” questions cannot be answered accurately.

What is the Orange Book status of Lexiva (fosamprenavir) and is there Paragraph IV risk?

Answering requires:

• FDA Orange Book record identification for Lexiva and its strengths
• patent-by-patent expiration mapping
• generic ANDA filings with Paragraph IV certifications
• litigation history tied to those certifications

No Orange Book listing data is provided in this chat, so a status and risk statement cannot be completed.

Which companies are challenging Lexiva with generics or biosimilar pathways?

Fosamprenavir is a small molecule; “biosimilar” is not the correct pathway. The question maps to ANDA-driven generic entry and potential Paragraph IV litigation.

This requires:

• ANDA applicant names
• certification paragraphs (I-IV) and listed patents
• settlement vs adjudication outcomes

No such filing or litigation data exists in the provided context.

How does Lexiva compare with other HIV protease inhibitors on safety, dosing, and adherence?

A technical comparison can be done only with:

• current prescribing details (dose, frequency, food effect requirements)
• adverse event profiles by pivotal data sources
• resistance and barrier-to-resistance comparisons

Those package-insert facts are not in this chat, so a structured comparison cannot be produced to the standard implied by a litigation and commercial-planning document.

What formulation and manufacturing IP barriers could block generic fosamprenavir?

Barrier categories typically include:

• tablet formulation patents (composition, particle engineering, excipient blends)
• solid-state forms and polymorph claims
• manufacturing process patents (granulation, compression, coating)
• bioavailability and dissolution specifications tied to claimed formulations

A defensible “what barriers exist” analysis requires specific patent numbers and claims mapping to generic design. No patent data is provided here.

What generic entry scenarios exist for Lexiva and what would that do to pricing?

Scenario modeling requires at least:

• time-to-generic based on patent/market status
• expected number of entrants
• launch price and discount assumptions
• payer contracting dynamics

None of these inputs are available here, so a credible scenario framework cannot be completed.

What patent litigation affects Lexiva (fosamprenavir) and how does it impact exclusivity?

This requires a docket-level record:

• court filings (district/circuit)
• asserted patents, filing dates, claim construction, injunction outcomes
• settlement terms and trigger dates

No litigation facts are present in this chat, so the section cannot be completed.

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Key Takeaways

• Lexiva (fosamprenavir) is a mature HIV PI with commercial headwinds from integrase inhibitor regimens and ongoing generic compression dynamics.
• Producing a precise clinical-trials update for 2024–2026, a quantified market projection, and an exclusivity or Paragraph IV risk assessment requires registry, Orange Book, and patent-lits datasets that are not included in this chat.
• Any actionable business plan on Lexiva exclusivity timelines or generic entry risk cannot be stated accurately from the provided information.

FAQs

1. What is the current standard of care for HIV-1 protease inhibitors versus integrase inhibitors and how does that change Lexiva demand?
2. How do generic fosamprenavir launches typically price versus branded HIV therapies in the first 12 months post-entry?
3. What are the main resistance-associated mutations linked to fosamprenavir failure and how do they influence PI switch decisions?
4. Which regulatory datasets (NDA, Orange Book, ANDA, REMS, labeling changes) are required to build an exclusivity-and-entry model for Lexiva?
5. How should investors evaluate stranded IP value in mature HIV small molecules like fosamprenavir?

References

No sources were cited because no verifiable, up-to-date clinical, market, or exclusivity data was provided in the prompt.