CLINICAL TRIALS PROFILE FOR SAQUINAVIR

All Clinical Trials for Saquinavir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000848 ↗	The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.
NCT00000891 ↗	Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the relationship between viral suppression and changes in immune function, as measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral therapy (HAART) in ACTG 315. To evaluate the durability of the antiviral and immunologic effects of long-term treatment with HAART. Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART.
NCT00000892 ↗	A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copies/ml after 16 weeks of treatment. To assess the safety, toxicity, and tolerance of each treatment arm. While indinavir is currently the most commonly prescribed protease inhibitor, the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown. Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure. This may involve the use of 1 or more reverse transcriptase inhibitors (RTIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). This study attempts to formally evaluate some of these options in indinavir-experienced patients.
NCT00000898 ↗	The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs.
NCT00000906 ↗	Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients	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 combine methadone with two HIV protease inhibitors (PIs), ritonavir (RTV) and saquinavir (SQV), in HIV-infected patients not currently taking PIs. This study will measure the interactions between methadone and the PIs. Methadone is used treat addicts and to treat severe pain. In order to find the safest way to use methadone with PIs, it is important to evaluate how they interact.
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.
NCT00000913 ↗	A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children	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 a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.

Clinical Trial Conditions for Saquinavir

Condition Name

Condition Name for Saquinavir
Intervention	Trials
HIV Infections	73
HIV Infection	3
Human Immunodeficiency Virus (HIV) Infection	1
Cardiovascular Disease	1

Condition MeSH

Condition MeSH for Saquinavir
Intervention	Trials
HIV Infections	77
Infections	14
Infection	11
Acquired Immunodeficiency Syndrome	11

Clinical Trial Locations for Saquinavir

Trials by Country

Trials by Country for Saquinavir
Location	Trials
United States	482
Canada	24
Puerto Rico	19
Thailand	12
Spain	11

Trials by US State

Trials by US State for Saquinavir
Location	Trials
California	42
New York	40
Illinois	27
Florida	26
Massachusetts	23

Clinical Trial Progress for Saquinavir

Clinical Trial Phase

Clinical Trial Phase for Saquinavir
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	11
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Saquinavir
Clinical Trial Phase	Trials
Completed	79
Terminated	5
Withdrawn	3

Clinical Trial Sponsors for Saquinavir

Sponsor Name

Sponsor Name for Saquinavir
Sponsor	Trials
Hoffmann-La Roche	26
National Institute of Allergy and Infectious Diseases (NIAID)	21
The HIV Netherlands Australia Thailand Research Collaboration	11

Sponsor Type

Sponsor Type for Saquinavir
Sponsor	Trials
Other	54
Industry	51
NIH	31

Saquinavir: Clinical Trials, Market Analysis, and Projections

Introduction

Saquinavir, a protease inhibitor, has been a significant component in the treatment of HIV-1 infection since its approval. Here, we will delve into the latest updates on clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

Pediatric Studies

The FDA has been keen on evaluating saquinavir for pediatric use. A key study aimed to assess the pharmacokinetics, safety, and efficacy of saquinavir in children. However, the study faced challenges, including methodological issues that rendered the data unreliable, necessitating revalidation of the analysis methods. Despite these hurdles, the objective remains to propose an appropriate dose of saquinavir for HIV-infected pediatric patients[1].

Combination Therapies

Clinical trials have also focused on combination therapies involving saquinavir. For instance, a study compared the antiretroviral activity of saquinavir with ritonavir or nelfinavir, along with other antiretroviral agents. The study found that virologic response did not differ significantly between the pooled ritonavir and nelfinavir groups, indicating that saquinavir can be effectively used in combination with other drugs[4].

Safety and Tolerability

Studies such as NV20911 and PACTG 397 have shown that saquinavir, when combined with ritonavir or other antiretroviral agents, is generally well-tolerated. However, adverse events (AEs) such as nasopharyngitis, cough, pyrexia, and diarrhea have been reported. Serious AEs were less common but included infections and gastrointestinal disorders[1].

Market Analysis

Global HIV Drugs Market

The global HIV drugs market, including injectables, is projected to surpass $35 billion in 2024 and is expected to see strong revenue growth through 2034. This growth is driven by the increasing demand for antiretroviral therapies and the development of new treatment options[2].

Segment Analysis

The market is segmented by drug class, with protease inhibitors like saquinavir being a significant segment. The protease inhibitors segment is expected to maintain its market share due to the efficacy of these drugs in combination therapies. The market attractiveness index for protease inhibitors remains high, indicating continued demand[2].

Distribution Channels

The distribution of HIV drugs, including saquinavir, is primarily through hospital pharmacies, retail pharmacies, and increasingly through online pharmacies. The market size and share by region and distribution channel are expected to grow, with hospital pharmacies remaining the dominant channel[2].

Projections

Market Size and Growth

The HIV drugs and injectables market is projected to continue its growth trajectory, driven by increasing global demand for antiretroviral therapies. By 2034, the market is expected to see significant expansion, with protease inhibitors like saquinavir contributing to this growth[2].

Regional Demand

The demand for HIV drugs, including saquinavir, varies by region. Low- and middle-income countries are expected to see a rise in demand due to increasing access to antiretroviral treatments. Global forecasts suggest that by 2024, approximately 31.7 million people will be receiving antiretroviral treatment, with this number expected to increase further[5].

Pipeline Analysis

The pipeline for HIV injectables and oral drugs is robust, with several new drugs and formulations in development. While saquinavir itself may not be at the forefront of new developments, its use in combination therapies and its established efficacy ensure its continued relevance in the market[2].

Potential Repurposing

Interestingly, saquinavir has been hypothesized as a potential candidate for treating COVID-19 due to its ability to disrupt host-virus interactions. This repurposing is based on machine learning models and docking studies, suggesting that saquinavir could be explored further in clinical trials for COVID-19 treatment[3].

Key Takeaways

• Clinical Trials: Saquinavir continues to be evaluated for pediatric use and in combination therapies, with a focus on safety and efficacy.
• Market Analysis: The global HIV drugs market is projected to grow significantly, with protease inhibitors like saquinavir maintaining their market share.
• Projections: The demand for HIV drugs is expected to rise globally, especially in low- and middle-income countries, driving market growth.
• Repurposing: Saquinavir is being considered for potential use in treating COVID-19, highlighting its versatility.

FAQs

What is the current status of saquinavir in pediatric clinical trials?

The pediatric clinical trials for saquinavir have faced methodological challenges, but the objective remains to determine an appropriate dose for HIV-infected pediatric patients.

How is saquinavir used in combination therapies?

Saquinavir is often used in combination with other antiretroviral agents, such as ritonavir or nelfinavir, to enhance its efficacy and tolerability.

What is the projected market size for HIV drugs, including saquinavir, by 2034?

The global HIV drugs market, including injectables, is expected to see strong revenue growth and surpass $35 billion by 2024, with continued growth through 2034.

Which distribution channels dominate the market for HIV drugs like saquinavir?

Hospital pharmacies currently dominate the distribution of HIV drugs, followed by retail and online pharmacies.

Is saquinavir being considered for any other medical uses beyond HIV treatment?

Yes, saquinavir has been hypothesized as a potential candidate for treating COVID-19 due to its ability to disrupt host-virus interactions.

What are the common adverse events associated with saquinavir?

Common adverse events include nasopharyngitis, cough, pyrexia, and diarrhea, with serious events being less common but including infections and gastrointestinal disorders.

Sources

1. FDA: "Saquinavir Clinical PREA - FDA" [PDF]
2. Research and Markets: "HIV Drugs and Injectables Market Report 2024-2034"
3. MedRxiv: "Repurposing Therapeutics for COVID-19: Rapid Prediction of Potential Drugs"
4. Journal of Infectious Diseases: "Randomized Study of Saquinavir with Ritonavir or Nelfinavir"
5. AIDS Data Hub: "Forecasts of Global and Regional Demand for 2020-2024" [PDF]