CLINICAL TRIALS PROFILE FOR FORTOVASE

All Clinical Trials for Fortovase

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000920 ↗	Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1	1969-12-31	The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn. Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it may be possible to reduce it further by using a combination of anti-HIV drugs. This study adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase inhibitor) to the mother's ZDV regimen.
NCT00000920 ↗	Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn. Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it may be possible to reduce it further by using a combination of anti-HIV drugs. This study adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase inhibitor) to the mother's ZDV regimen.
NCT00002229 ↗	Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients	Completed	Hoffmann-La Roche	Phase 4	1969-12-31	The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.
NCT00002378 ↗	A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients	Completed	Hoffmann-La Roche	Phase 3	1969-12-31	To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens. AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection (< 400 copies/ml) at week 24 and week 48.
NCT00002397 ↗	A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease	Completed	Hoffmann-La Roche	Phase 3	1969-12-31	The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening. This study also examines the effect these drug combinations have on the level of HIV detected in these patients. Finally, this study evaluates the drug level (the amount of drug found in the body) of these two combinations in patients with kidney disease.

Clinical Trial Conditions for Fortovase

Condition Name

Condition Name for Fortovase
Intervention	Trials
HIV Infections	8
AIDS-Associated Nephropathy	1
Directly Observed Therapy	1
Pregnancy	1

Condition MeSH

Condition MeSH for Fortovase
Intervention	Trials
HIV Infections	8
Kidney Diseases	1
AIDS-Associated Nephropathy	1

Clinical Trial Locations for Fortovase

Trials by Country

Trials by Country for Fortovase
Location	Trials
United States	71
Puerto Rico	4
Canada	4
Germany	1
United Kingdom	1

Trials by US State

Trials by US State for Fortovase
Location	Trials
New Jersey	6
California	5
New York	5
Illinois	4
Florida	4

Clinical Trial Progress for Fortovase

Clinical Trial Phase

Clinical Trial Phase for Fortovase
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Fortovase
Clinical Trial Phase	Trials
Completed	7
Terminated	1

Clinical Trial Sponsors for Fortovase

Sponsor Name

Sponsor Name for Fortovase
Sponsor	Trials
Hoffmann-La Roche	6
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	1
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for Fortovase
Sponsor	Trials
Industry	7
NIH	2
Other	1

Clinical Trials, Market Analysis, and Projections for FORTOVASE (Saquinavir)

Introduction

FORTOVASE, the soft gel formulation of saquinavir, is a protease inhibitor used in the treatment of HIV-1 infection. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy and Safety

Clinical trials for FORTOVASE have focused on its efficacy, safety, and pharmacokinetics. A key study, PACTG 397, involved pediatric patients aged 3 to 16 years and assessed the safety, tolerability, bioavailability, and efficacy of FORTOVASE alone or in combination with other antiretroviral agents like ritonavir (RTV) and nelfinavir (NFV)[1].

• Pharmacokinetics: The study showed that combining FORTOVASE with RTV significantly increased the area under the plasma concentration-time curve (AUC) and trough levels of saquinavir compared to combination with NFV. This boost in pharmacokinetic parameters was crucial for achieving therapeutic levels of the drug[1].

• Viral Load and CD4 Count: In another study, NV15355C, FORTOVASE in combination with two reverse transcriptase inhibitors (RTIs) demonstrated superior viral load suppression compared to the hard-gel formulation (INVIRASE). At 16 weeks, 80% of patients on FORTOVASE had viral loads below 500 copies/mL, compared to 43% on INVIRASE[2][5].

• Adverse Events: The trials reported that FORTOVASE, especially when boosted with RTV, was generally well-tolerated. Common adverse events included nasopharyngitis, cough, pyrexia, and diarrhea. Serious adverse events were relatively rare, with infections and gastrointestinal disorders being the most common[1].

Pediatric Studies

Pediatric studies were critical in understanding the drug's behavior in younger patients. However, the pharmacokinetic data showed significant intra-subject variability, making it challenging to determine appropriate dosing for the youngest patients[1].

Market Analysis

Current Market Trends

The global clinical trials market, which includes trials for drugs like FORTOVASE, is projected to grow significantly. From $61.58 billion in 2024, the market is expected to reach $106.78 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 7.1%[3].

• Growing Demand: The increasing prevalence of chronic diseases, including HIV, drives the demand for clinical trials. This trend is expected to continue, fueling market growth[3].

• Cost-Effectiveness: Many clinical trials are conducted outside the U.S. and European Union due to cost-effectiveness and easier regulatory processes. This shift could impact the market dynamics for drugs like FORTOVASE[3].

Competitive Landscape

FORTOVASE faced significant competition in the protease inhibitor market. Roche's marketing efforts were intense, especially after saquinavir did not make the cut as a strongly recommended first-line protease inhibitor in the HHS Clinical Practice Guidelines. This led to accelerated FDA approval and aggressive marketing of the soft-gel formulation[2].

Market Projections

Future Growth

Despite the challenges and competition, FORTOVASE has a niche in the HIV treatment market, particularly in regions where access to newer antiretrovirals is limited.

• Emerging Markets: The demand for effective HIV treatments in emerging markets is likely to sustain the market for FORTOVASE. The drug's bioavailability and efficacy when boosted with RTV make it a viable option in these regions[5].

• Combination Therapies: The success of FORTOVASE in combination with other antiretrovirals, such as RTV and nelfinavir, suggests continued relevance in treatment regimens. Quadruple therapy regimens, which include FORTOVASE and other protease inhibitors, have shown durable responses and could drive future demand[4].

Drug Interactions and Safety Considerations

Pharmacokinetic Interactions

FORTOVASE interacts significantly with other drugs, particularly those used in HIV treatment. For example:

• Ritonavir: Boosting FORTOVASE with RTV significantly increases saquinavir plasma concentrations, making it a crucial component of many treatment regimens[4][5].

• Nelfinavir: Co-administration with nelfinavir also enhances saquinavir levels, though it may increase the incidence of diarrhea[4].

• Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): Delavirdine co-administration with FORTOVASE can lead to hepatocellular enzyme elevations, while nevirapine decreases saquinavir AUC, though this is not considered clinically significant[4].

Key Takeaways

• Clinical Efficacy: FORTOVASE has demonstrated superior viral load suppression and CD4 count improvements when compared to its hard-gel counterpart, especially when boosted with RTV.
• Market Growth: The global clinical trials market is expected to grow, driven by the increasing demand for treatments for chronic diseases.
• Competitive Landscape: Despite initial marketing challenges, FORTOVASE remains a viable option in HIV treatment, particularly in emerging markets.
• Drug Interactions: Careful consideration of pharmacokinetic interactions is necessary when using FORTOVASE in combination therapies.

FAQs

Q: What is FORTOVASE, and how does it differ from INVIRASE?

A: FORTOVASE is the soft gel formulation of saquinavir, a protease inhibitor used in HIV treatment. It has higher bioavailability compared to INVIRASE, the hard-gel formulation, especially when boosted with ritonavir[2][5].

Q: What were the key findings of the PACTG 397 study?

A: The PACTG 397 study showed that combining FORTOVASE with RTV significantly increased saquinavir plasma concentrations and was well-tolerated in pediatric patients. However, it highlighted significant intra-subject variability in pharmacokinetic parameters[1].

Q: How does FORTOVASE interact with other HIV medications?

A: FORTOVASE interacts significantly with other HIV medications. Boosting with RTV increases its plasma concentrations, while co-administration with nelfinavir and certain NNRTIs can lead to various pharmacokinetic and safety considerations[4].

Q: What is the projected market growth for clinical trials, and how does it impact FORTOVASE?

A: The global clinical trials market is projected to grow to $106.78 billion by 2032, driven by the increasing demand for treatments for chronic diseases. This growth trend is expected to sustain the market for FORTOVASE, particularly in emerging markets[3].

Q: What are the common adverse events associated with FORTOVASE?

A: Common adverse events associated with FORTOVASE include nasopharyngitis, cough, pyrexia, and diarrhea. Serious adverse events are relatively rare but can include infections and gastrointestinal disorders[1].

Sources

1. FDA: Saquinavir Clinical PREA - FDA.
2. Treatment Action Group: Scammed: Roche Racks Up Millions In Early Saquinavir Sales.
3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032].
4. European Commission: Fortovase, INN-Saquinavir.
5. Medicines.org.au: FORTOVASE® soft gelatin capsules.