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
Immunologic Deficiency Syndromes	4
Acquired Immunodeficiency Syndrome	4
Infections	2

Clinical Trial Locations for Lexiva

Trials by Country

Trials by Country for Lexiva
Location	Trials
United States	56
Germany	4
Canada	3
Italy	3
Poland	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
Emory University	1

Sponsor Type

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

Clinical Trials, Market Analysis, and Projections for Lexiva

Introduction to Lexiva

Lexiva, also known as fosamprenavir calcium, is a protease inhibitor (PI) used in the treatment of HIV infection. It was co-discovered by GlaxoSmithKline (GSK) and Vertex Pharmaceuticals and approved by the FDA in October 2003.

Clinical Trials Update

Long-Term Efficacy and Tolerability

Studies presented at the International AIDS Conference (IAC) in 2004 demonstrated the sustained efficacy and tolerability of Lexiva after 96 weeks of treatment. In these studies, Lexiva was used in combination with abacavir and lamivudine, either with or without ritonavir. The results showed that Lexiva/r QD (once daily) and Lexiva BID (twice daily) maintained virologic suppression and immunologic improvements without selecting for PI-resistant mutations[1].

• Virologic Suppression: For patients taking Lexiva/r QD, 96% had viral loads below 400 copies/mL, and 86% had viral loads below 50 copies/mL at 96 weeks.
• Immunologic Improvements: Median CD4 cell counts increased significantly from baseline to week 96.
• Safety Profile: The treatment was well-tolerated, with low discontinuation rates due to adverse events.

Ongoing and Completed Trials

Apart from the HIV treatment trials, there have been exploratory studies on the use of Lexiva for other conditions. For instance, a Phase 3 clinical trial was conducted to evaluate the efficacy of Lexiva in treating laryngopharyngeal reflux (LPR), although this trial is no longer recruiting patients[4].

Market Analysis

Active Pharmaceutical Ingredients Market

While Lexiva itself is not a major player in the broader active pharmaceutical ingredients (API) market, the market for APIs is growing significantly. The global API market is expected to grow by USD 97.6 billion from 2025 to 2029, driven by advancements in API manufacturing in developing regions and increased research in various therapeutic areas[2].

HIV Treatment Market

The HIV treatment market, where Lexiva is a part of, is influenced by several factors including the development of new antiretroviral therapies, patient adherence, and access to healthcare. The market for HIV treatments continues to evolve with new drugs and combination therapies being introduced.

Market Projections

HIV Antiretroviral Market

The market for HIV antiretroviral therapies is expected to continue growing due to the increasing prevalence of HIV and the need for effective and tolerable treatments. However, Lexiva, being an older drug, may face competition from newer antiretroviral agents that offer improved efficacy, safety, and convenience.

Generic and Biosimilar Impact

As patents for many antiretroviral drugs expire, the market is likely to see an increase in generic and biosimilar versions. This trend could impact the market share of branded drugs like Lexiva, although it may also make treatment more accessible and affordable for a wider population.

Safety and Efficacy Profile

Adverse Events

The common adverse events associated with Lexiva include diarrhea, nausea, and rash. The discontinuation rate due to adverse events is relatively low, indicating a favorable safety profile[1].

Resistance Mutations

One of the significant advantages of Lexiva is its ability to maintain efficacy without selecting for PI-resistant mutations over long-term treatment, which is crucial for the management of HIV infection[1].

Key Takeaways

• Sustained Efficacy: Lexiva has demonstrated sustained virologic suppression and immunologic improvements over 96 weeks of treatment.
• Tolerability: The drug is well-tolerated with a low discontinuation rate due to adverse events.
• Market Dynamics: The HIV treatment market is evolving with new drugs and combination therapies, which may impact Lexiva's market share.
• Generic and Biosimilar Impact: The introduction of generic and biosimilar versions could make HIV treatments more accessible but may also affect the market share of branded drugs.

FAQs

What is Lexiva used for?

Lexiva, or fosamprenavir calcium, is primarily used in the treatment of HIV infection, often in combination with other antiretroviral drugs.

What are the common adverse events associated with Lexiva?

The most common moderate to severe drug-related adverse events include diarrhea, nausea, and rash[1].

How effective is Lexiva in long-term treatment?

Studies have shown that Lexiva maintains virologic suppression and immunologic improvements over 96 weeks of treatment without selecting for PI-resistant mutations[1].

Is Lexiva being explored for other medical conditions?

Yes, there have been clinical trials exploring the use of Lexiva for conditions such as laryngopharyngeal reflux (LPR), although these trials are not currently active[4].

How does the market for HIV treatments impact Lexiva?

The market for HIV treatments is competitive, with new drugs and combination therapies being introduced. This competition, along with the potential for generic and biosimilar versions, could impact Lexiva's market share.

Sources

1. Studies of Sustained Efficacy/Tolerability of LEXIVA After 96 Weeks of Treatment Presented at IAC. Vertex Pharmaceuticals, July 13, 2004.
2. Active Pharmaceutical Ingredients Market to Grow by USD 97.6 Billion (2025-2029). Technavio, January 4, 2025.
3. Pfizer Reports Additional Data on PAXLOVID™ Supporting Efficacy and Safety. Pfizer, June 14, 2022.
4. Lexiva for Laryngopharyngeal Reflux - Clinical Trials. WithPower.
5. Global Bevacizumab Biosimilars Market Outlook 2024-2028 & 2033. GlobeNewswire, March 6, 2024.

Last updated: 2025-01-07