CLINICAL TRIALS PROFILE FOR RALTEGRAVIR POTASSIUM

All Clinical Trials for raltegravir potassium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00293254 ↗	A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-02-01	This study will investigate the safety and efficacy of raltegravir as a therapy for Human Immunodeficiency Virus (HIV)-infected patients failing current therapy with 3-class antiviral resistance.
NCT00293267 ↗	A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-02-01	This study will investigate the safety and efficacy of raltegravir as a therapy for HIV-infected patients failing current therapy with 3-class antiviral resistance.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	Janssen-Cilag Tibotec	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	French National Agency for Research on AIDS and Viral Hepatitis	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT01022476 ↗	Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients	Completed	Merck Sharp & Dohme Corp.	Phase 1/Phase 2	2010-05-01	This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.
NCT01022476 ↗	Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients	Completed	ANRS, Emerging Infectious Diseases	Phase 1/Phase 2	2010-05-01	This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.

Clinical Trial Conditions for raltegravir potassium

Condition Name

Condition Name for raltegravir potassium
Intervention	Trials
HIV Infections	4
Evidence of Liver Transplantation	1
Hepatitis C	1
HIV Infection	1

Condition MeSH

Condition MeSH for raltegravir potassium
Intervention	Trials
HIV Infections	5
End Stage Liver Disease	1
Hepatitis C	1
Hepatitis A	1

Clinical Trial Locations for raltegravir potassium

Trials by Country

Trials by Country for raltegravir potassium
Location	Trials
France	2
Ireland	1

Clinical Trial Progress for raltegravir potassium

Clinical Trial Phase

Clinical Trial Phase for raltegravir potassium
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for raltegravir potassium
Clinical Trial Phase	Trials
Completed	4
Unknown status	1

Clinical Trial Sponsors for raltegravir potassium

Sponsor Name

Sponsor Name for raltegravir potassium
Sponsor	Trials
Merck Sharp & Dohme Corp.	4
Janssen-Cilag Tibotec	1
French National Agency for Research on AIDS and Viral Hepatitis	1

Sponsor Type

Sponsor Type for raltegravir potassium
Sponsor	Trials
Other	5
Industry	4

Raltegravir potassium Market Analysis and Financial Projection

Raltegravir Potassium: Clinical Trials, Market Analysis, and Projections

Introduction

Raltegravir potassium, marketed under the brand name Isentress, is an integrase inhibitor used in the treatment of HIV-1 infection. This article provides an update on the clinical trials, market analysis, and projections for this crucial antiretroviral drug.

Clinical Trials Overview

Efficacy and Safety in Adults

Clinical trials have demonstrated the efficacy and safety of raltegravir potassium in treating HIV-1 infection. A long-term study involving 462 patients treated with raltegravir and 237 with placebo showed significant viral load reduction and CD4 cell count increase. At week 156, 51% of the raltegravir group had viral loads of less than 50 copies per mL, compared to 22% in the placebo group. By week 240, these numbers remained favorable, with 42% of the raltegravir group achieving viral loads below 50 copies per mL and a mean CD4 cell count increase of 183 cells per μL[1].

Pediatric Clinical Trials

In pediatric patients, raltegravir potassium has also shown promising results. A Phase I/II trial involving 126 treatment-experienced pediatric subjects aged 2 years and older demonstrated that raltegravir, in combination with other antiretroviral drugs, significantly reduced HIV-1 RNA viral load and increased CD4 cell counts. By week 24, 53% of the subjects achieved HIV RNA levels below 50 copies per mL, and 66% had levels below 400 copies per mL[4].

Safety Profile

Adverse Events and Toxicity

The safety profile of raltegravir potassium is generally favorable. Clinical studies have shown that the drug is well-tolerated, with no drug-related clinical adverse events occurring at frequencies of at least 2% greater than in the placebo group. However, further monitoring for resistance to raltegravir and the risk of malignancies is recommended[3].

Preclinical Studies

Preclinical studies in animals, including mice, rats, and dogs, have evaluated the toxicity of raltegravir. These studies indicated that raltegravir does not affect cardiovascular, respiratory, or renal functions significantly. However, high doses in some animal models showed minor adverse effects such as stomach mucosa irritation and increased gastrointestinal motility[3].

Market Analysis

Current Market Size and Growth

The Raltegravir Potassium Sales Market has experienced rapid growth in recent years. As of 2023, the market size is substantial, and projections indicate continued significant expansion until 2031. The market is segmented by type (tablets, oral suspension) and application (HIV-AIDS), with geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[2].

Market Dynamics

The positive trend in market dynamics is driven by several factors, including the increasing prevalence of HIV, the need for effective antiretroviral therapies, and the favorable safety and efficacy profile of raltegravir potassium. The market is expected to grow robustly, reflecting strong growth rates over the forecast period from 2023 to 2031[2].

API Market

The Raltegravir Potassium API Market is also on a trajectory of significant growth. This market is categorized by type (above 98%, above 99%) and application (tablets, others), with similar geographical segments. The outlook for this market is optimistic, with projections indicating continued expansion and robust growth rates until 2031[5].

Market Projections

Revenue Growth

Both the Raltegravir Potassium Sales Market and the API Market are anticipated to achieve substantial revenue growth. The comprehensive market reports forecast trends and provide detailed analyses of market dynamics, including drivers, restraints, opportunities, and challenges. These analyses suggest that the markets will continue to expand significantly over the next several years[2][5].

Geographical Trends

The growth of the raltegravir potassium market is expected to be driven by various geographical regions. North America and Europe are likely to remain key markets, while the Asia-Pacific region is anticipated to show significant growth due to increasing demand for antiretroviral therapies and improving healthcare infrastructure[2][5].

Key Players and Competitive Landscape

Market Competition

The market for raltegravir potassium is competitive, with several key players involved in its production and distribution. Merck & Co., the original developer of Isentress, remains a major player. Other companies are also entering the market, particularly in the API segment, contributing to the competitive landscape[2][5].

Consumer Behavior and Public Health Impact

Patient Compliance and Outcomes

The efficacy of raltegravir potassium in clinical trials translates into improved patient outcomes in real-world settings. Patient compliance with the twice-daily dosing regimen is crucial for achieving and maintaining viral suppression. Public health initiatives aimed at increasing access to antiretroviral therapies, including raltegravir potassium, are expected to drive market growth and improve health outcomes for HIV patients globally[1][4].

Regulatory Approvals and Updates

FDA and EMA Approvals

Raltegravir potassium received accelerated approval from the FDA in 2007 for the treatment of HIV-1 infection in treatment-experienced adults. The drug has also been approved by the European Medicines Agency (EMA) under a Conditional Marketing Authorization, highlighting its positive risk-benefit profile and unmet medical need[3][4].

Conclusion

Raltegravir potassium is a critical component in the treatment of HIV-1 infection, with a strong clinical trials record and a favorable safety profile. The market for this drug is poised for significant growth, driven by increasing demand for effective antiretroviral therapies and expanding access to healthcare in various regions.

Key Takeaways

• Clinical Efficacy: Raltegravir potassium has demonstrated significant efficacy in reducing viral loads and increasing CD4 cell counts in both adult and pediatric patients.
• Safety Profile: The drug is generally well-tolerated, with a favorable safety profile and minimal adverse effects.
• Market Growth: The Raltegravir Potassium Sales Market and API Market are expected to experience robust growth until 2031.
• Geographical Trends: North America, Europe, and the Asia-Pacific region are key markets driving growth.
• Regulatory Approvals: Approved by FDA and EMA, highlighting its positive risk-benefit profile.

FAQs

Q: What is the recommended dosage of raltegravir potassium?

A: The recommended dosage is 400 mg administered twice daily[3].

Q: What are the key segments of the Raltegravir Potassium Sales Market?

A: The market is segmented by type (tablets, oral suspension) and application (HIV-AIDS), with geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[2].

Q: Has raltegravir potassium been approved for pediatric use?

A: Yes, it has been approved for use in pediatric patients aged 2 years and older in combination with other antiretroviral drugs[4].

Q: What are the potential side effects of raltegravir potassium?

A: While generally well-tolerated, high doses in animal studies showed minor adverse effects such as stomach mucosa irritation and increased gastrointestinal motility. In humans, it is recommended to monitor for resistance and the risk of malignancies[3].

Q: What is the outlook for the Raltegravir Potassium API Market?

A: The market is anticipated to achieve substantial growth until 2031, driven by increasing demand for antiretroviral therapies and expanding access to healthcare[5].

Sources

1. Efficacy and safety of raltegravir for treatment of HIV for 5 years in ... - PubMed
2. Raltegravir Potassium Sales Market Size, Scope And Forecast Report - Market Research Intellect
3. Isentress, INN-raltegravir - European Medicines Agency
4. Raltegravir N22 145S022 Clinical PREA | FDA - FDA
5. Raltegravir Potassium API Market Size, Scope And Forecast Report - Market Research Intellect