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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR VIRAMUNE XR


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All Clinical Trials for Viramune Xr

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002166 ↗ An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease Completed Boehringer Ingelheim Phase 3 1969-12-31 To provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive, symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are unable to participate in another Viramune controlled clinical trial and have a compelling need for anti-HIV treatment.
NCT00002194 ↗ An Open-Label Study in HIV+ Patients to Determine the Effects of Nevirapine (Viramune) on the Pharmacokinetics of Clarithromycin and Activity of Cytochrome 3A4. Completed Boehringer Ingelheim Phase 1 1969-12-31 To evaluate the potential pharmacokinetic interaction between nevirapine and clarithromycin, and to determine the effects of nevirapine on cytochrome P450 3A4 (CYP3A4) activity in vivo.
NCT00002368 ↗ The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs Completed Boehringer Ingelheim Phase 3 1969-12-31 To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
NCT00002381 ↗ The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine Completed Boehringer Ingelheim Phase 1 1969-12-31 To determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the historical controls treated with nevirapine but without nelfinavir or d4T. To determine the efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor naive, and have <= 6 months prior d4T exposure at the time of screening.
NCT00002418 ↗ The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors Terminated Boehringer Ingelheim Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
NCT00002418 ↗ The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors Terminated Triangle Pharmaceuticals Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
NCT00002418 ↗ The Safety and Effectiveness of Didanosine Plus Stavudine Plus Nevirapine Combined With MKC-442 in HIV-Infected Patients Who Have Not Had Success With Protease Inhibitors Terminated Bristol-Myers Squibb Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give a new anti-HIV drug combination to HIV-infected patients who have never taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) and who have failed to respond to protease inhibitors (PIs). The drug combination will contain didanosine (ddI) plus stavudine (d4T) plus nevirapine (NVP) plus MKC-442. Hydroxyurea (HU) may be added.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Viramune Xr

Condition Name

Condition Name for Viramune Xr
Intervention Trials
HIV Infections 30
HIV 3
Healthy 2
Hepatic Insufficiency 2
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Condition MeSH

Condition MeSH for Viramune Xr
Intervention Trials
HIV Infections 33
Acquired Immunodeficiency Syndrome 8
Infections 3
Infection 3
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Clinical Trial Locations for Viramune Xr

Trials by Country

Trials by Country for Viramune Xr
Location Trials
United States 56
Brazil 7
Spain 6
South Africa 5
Thailand 5
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Trials by US State

Trials by US State for Viramune Xr
Location Trials
California 6
Rhode Island 4
New York 4
Florida 3
Texas 3
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Clinical Trial Progress for Viramune Xr

Clinical Trial Phase

Clinical Trial Phase for Viramune Xr
Clinical Trial Phase Trials
Phase 4 13
Phase 3 6
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Viramune Xr
Clinical Trial Phase Trials
Completed 39
Terminated 3
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Clinical Trial Sponsors for Viramune Xr

Sponsor Name

Sponsor Name for Viramune Xr
Sponsor Trials
Boehringer Ingelheim 26
National Institute of Allergy and Infectious Diseases (NIAID) 5
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 5
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Sponsor Type

Sponsor Type for Viramune Xr
Sponsor Trials
Industry 33
Other 30
NIH 13
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Clinical Trials, Market Analysis, and Projections for Viramune XR

Introduction

Viramune XR, the extended-release formulation of nevirapine, is a significant advancement in the treatment of HIV-1 infection. This article delves into the clinical trials that led to its approval, its market analysis, and projections for its future impact.

Clinical Trials Overview

VERxVE Trial

The approval of Viramune XR was primarily based on the VERxVE trial (Trial 1100.1486), a Phase III, randomized, double-blind, double-dummy study. This trial compared the efficacy, safety, and tolerability of once-daily Viramune XR (400 mg) to twice-daily immediate-release Viramune (200 mg) in treatment-naive adult patients. All patients received a 14-day lead-in period with immediate-release Viramune 200 mg once daily, followed by randomization to either treatment group. The trial also included a nucleoside reverse transcriptase inhibitor (NRTI) backbone of tenofovir and emtricitabine[3][5].

Key Findings

  • Virologic Response: The trial demonstrated that Viramune XR achieved a virologic response non-inferior to immediate-release Viramune through 48 weeks. Specifically, 80% of patients on Viramune XR and 75% on immediate-release Viramune achieved a viral load of <50 copies/mL[3].
  • Safety and Tolerability: The incidence of hepatic events was comparable between the two groups, with 6% in the Viramune XR group and 9% in the immediate-release group. Symptomatic hepatic events were also similar, at 2% and 3%, respectively. Rash and Stevens-Johnson syndrome were rare but significant adverse reactions, with most cases occurring within the first 30 days of treatment[3][5].

TRANxITION Trial

The TRANxITION trial, another Phase III study, supported the safety and efficacy of switching from immediate-release Viramune to Viramune XR in HIV-1 infected adults. This study showed that patients could safely and effectively switch to the once-daily regimen without compromising efficacy or safety[3].

Market Analysis

Market Size and Growth

The market for antiretroviral drugs, including Viramune XR, is part of a broader pharmaceutical landscape. However, to contextualize the growth potential, it's important to note that the global antiretroviral market is influenced by various factors, including new drug approvals and advancements in treatment regimens.

Competitive Landscape

Viramune XR competes in a market dominated by other antiretroviral therapies. The approval of Viramune XR provides patients and healthcare providers with a once-daily dosing option, which can enhance adherence and quality of life. This differentiation can be a significant market driver, especially given the non-inferior efficacy and comparable safety profile to the immediate-release formulation[3][5].

Projections and Future Outlook

Patient Adherence and Quality of Life

The once-daily dosing of Viramune XR is expected to improve patient adherence, a critical factor in the management of HIV-1 infection. Improved adherence can lead to better viral suppression and reduced risk of drug resistance, ultimately enhancing the overall quality of life for patients.

Market Expansion

Given the global need for effective HIV treatments, Viramune XR is poised for significant market expansion. The drug's approval in the U.S. and potential approval in other regions, such as Europe, will expand its reach and impact. The 14-day lead-in period with immediate-release nevirapine, which reduces the frequency of rash, is a crucial aspect of its safety profile that will influence its adoption[3][5].

Safety Considerations and Monitoring

Hepatotoxicity and Rash

Viramune XR, like its immediate-release counterpart, carries risks of hepatotoxicity and severe rash. Patients with higher CD4+ cell counts (females > 250 cells/mm³, males > 400 cells/mm³) should not initiate therapy without careful risk-benefit assessment. Intensive clinical and laboratory monitoring during the first 18 weeks of therapy is essential to detect potentially life-threatening skin reactions and hepatic events[1][4].

Consumer and Healthcare Provider Perspectives

Enhanced Convenience

The once-daily dosing of Viramune XR offers enhanced convenience for patients, which can improve treatment adherence. Healthcare providers also benefit from the simplified dosing regimen, as it can reduce the complexity of managing HIV treatment plans.

Cost and Accessibility

The cost-effectiveness of Viramune XR will be a key factor in its market success. As with many antiretroviral therapies, accessibility and affordability are crucial for widespread adoption, especially in resource-limited settings.

Key Takeaways

  • Clinical Efficacy: Viramune XR has demonstrated non-inferior efficacy to immediate-release Viramune in clinical trials.
  • Safety Profile: The drug has a comparable safety profile to its immediate-release counterpart, with careful monitoring required for hepatotoxicity and rash.
  • Market Potential: The once-daily dosing regimen is expected to enhance patient adherence and quality of life, driving market expansion.
  • Global Reach: Approval in multiple regions will increase the drug's availability and impact.

FAQs

Q: What is the primary difference between Viramune XR and immediate-release Viramune?

A: Viramune XR is an extended-release formulation, allowing for once-daily dosing, whereas immediate-release Viramune is dosed twice daily.

Q: What are the key safety concerns associated with Viramune XR?

A: The primary safety concerns include hepatotoxicity and severe rash, particularly during the initial 18 weeks of therapy.

Q: How does the 14-day lead-in period with immediate-release Viramune impact the treatment?

A: The lead-in period reduces the frequency of rash and is a critical component of the treatment regimen to ensure patient safety.

Q: What are the implications of Viramune XR for patient adherence?

A: The once-daily dosing regimen is expected to improve patient adherence, leading to better viral suppression and reduced risk of drug resistance.

Q: Is Viramune XR approved for use in all patient populations?

A: No, patients with higher CD4+ cell counts (females > 250 cells/mm³, males > 400 cells/mm³) should not initiate therapy without careful risk-benefit assessment due to the risk of hepatotoxicity.

Sources

  1. Boehringer Ingelheim. VIRAMUNE XR® (nevirapine) extended-release tablets, for oral use. [PDF]
  2. Mordor Intelligence. Extended Reality (XR) Market Size, Companies & Share.
  3. PR Newswire. FDA Approves One-Pill, Once-Daily Viramune® XR™ (nevirapine) extended-release tablets for use in combination with other antiretroviral agents for treatment of HIV-1 infection in adults.
  4. Boehringer Ingelheim. VIRAMUNE® (nevirapine) oral suspension, for oral use. [PDF]
  5. HIV i-Base. FDA approve nevirapine XR.

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