CLINICAL TRIALS PROFILE FOR TIPRANAVIR

505(b)(2) Clinical Trials for TIPRANAVIR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02244190 ↗	Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers	Completed	Boehringer Ingelheim	Phase 1	2008-04-01	To establish the bioequivalence of the new tipranavir oral solution formulation with the current tipranavir oral solution formulation following single-dose administration. In each case, 500 mg tipranavir was coadministered with 200 mg ritonavir.

All Clinical Trials for TIPRANAVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00054717 ↗	Randomized Evaluation of Strategic Intervention in Multidrug Resistant Patients With Tipranavir (RESIST)	Completed	Boehringer Ingelheim	Phase 3	2003-01-01	Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.
NCT00056641 ↗	Dual Boosted - Protease Inhibitor (PI) Pharmacokinetics (PK) Trial (Tipranavir / Ritonavir) in Highly Treatment-experienced HIV-1 Infected Patients	Completed	Boehringer Ingelheim	Phase 2	2003-01-01	This is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (TPV/RTV), alone or in combination with RTV-boosted saquinavir (SQV), amprenavir (APV) or lopinavir (LPV), plus an optimized background regimen, in multiple antiretroviral (ARV) experienced HIV-1 patients. The primary objective is to determine the safety and pharmacokinetics of: TPV/RTV given with an optimized background regimen (OBR) and TPV/RTV given in combination with saquinavir, amprenavir, or Kaletra® and an optimized background regimen (OBR).
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	PENTA Foundation	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00034866 ↗	Dose Ranging Trial of Tipranavir/Ritonavir in Treatment-Experienced HIV Infected Individuals	Completed	Boehringer Ingelheim	Phase 2	2002-04-01	The purpose of this research study is to determine which of three different dose combinations of tipranavir and ritonavir, when taken with a standard approved anti-HIV drug therapy, is most effective and safe. Tipranavir is an investigational protease inhibitor which has been demonstrated to have in vitro activity against HIV-1.

Clinical Trial Conditions for TIPRANAVIR

Condition Name

Condition Name for TIPRANAVIR
Intervention	Trials
HIV Infections	34
Healthy	26
Infection, Human Immunodeficiency Virus	2
Hepatic Insufficiency	2

Condition MeSH

Condition MeSH for TIPRANAVIR
Intervention	Trials
HIV Infections	37
Infections	6
Communicable Diseases	6
Infection	5

Clinical Trial Locations for TIPRANAVIR

Trials by Country

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−

Trials by Country for TIPRANAVIR
Location	Trials
United States	274
Canada	34
Australia	15
Germany	13
Spain	12

Trials by US State

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−

Trials by US State for TIPRANAVIR
Location	Trials
Texas	15
Florida	13
California	13
North Carolina	12
New York	12

Clinical Trial Progress for TIPRANAVIR

Clinical Trial Phase

Clinical Trial Phase for TIPRANAVIR
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	8
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for TIPRANAVIR
Clinical Trial Phase	Trials
Completed	54
Terminated	9
Approved for marketing	3

Clinical Trial Sponsors for TIPRANAVIR

Sponsor Name

Sponsor Name for TIPRANAVIR
Sponsor	Trials
Boehringer Ingelheim	56
GlaxoSmithKline	3
Germans Trias i Pujol Hospital	2

Sponsor Type

Sponsor Type for TIPRANAVIR
Sponsor	Trials
Industry	64
Other	18
NIH	5

Tipranavir: Clinical Trials, Market Analysis, and Projections

Introduction

Tipranavir, marketed under the brand name APTIVUS, is a nonpeptidic protease inhibitor used in the treatment of HIV-1 infection, particularly in patients who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors. Here, we will delve into the clinical trials, market analysis, and projections for this crucial antiretroviral drug.

Clinical Trials Overview

Efficacy and Safety in Adults

Tipranavir, when co-administered with ritonavir, has been extensively studied in clinical trials involving treatment-experienced HIV-1 infected patients. The RESIST-1 trial, for example, compared the efficacy and safety of ritonavir-boosted tipranavir (TPV/r) with investigator-selected ritonavir-boosted comparator protease inhibitors (CPI/r). This study demonstrated that TPV/r showed superior antiviral activity, with 41.5% of patients achieving a ≥1 log10 reduction in HIV-1 load at week 24, compared to 22.3% in the CPI/r group[1].

In another set of controlled clinical trials (1182.12 and 1182.48), tipranavir co-administered with ritonavir was evaluated in 6308 HIV-1 positive adults. These trials showed that TPV/r resulted in significant reductions in HIV-1 viral load and increases in CD4 cell counts over a 48-week period. However, adverse reactions such as diarrhea, nausea, vomiting, and elevations in liver enzymes and lipid levels were more common in the TPV/r group[4].

Pediatric Studies

Tipranavir has also been studied in pediatric patients aged 2 to 18 years. A phase 1/2a study stratified children by age and randomized them to receive either a high or low dose of TPV/r. The study found that the higher dose was more effective in achieving viral load reductions, especially in older children with multiple baseline tipranavir-associated mutations. Despite a higher incidence of hepatic adverse events in the high-dose group, the overall safety profile was deemed acceptable, and the benefit of successful treatment outweighed the risks[3].

Market Analysis

Current Market Status

The tipranavir market is part of the broader antiretroviral therapy market, which is driven by the need for effective treatments for HIV-1 infection. Tipranavir's unique position as a nonpeptidic protease inhibitor makes it a valuable option for patients with multidrug-resistant HIV-1 strains.

Market Trends and Drivers

The global tipranavir market is influenced by several key factors:

• Increasing Prevalence of HIV-1: The ongoing need for antiretroviral therapies, especially for treatment-experienced patients, drives the demand for drugs like tipranavir.
• Resistance to Other Protease Inhibitors: The emergence of resistance to other protease inhibitors makes tipranavir a critical alternative.
• Advancements in Formulations: The availability of both capsule and oral solution formulations of tipranavir enhances its market appeal, particularly in pediatric and geriatric populations[2].

Regional Analysis

The tipranavir market is expected to be dominated by regions with high HIV-1 prevalence and advanced healthcare systems. North America and Europe are likely to be significant markets due to their well-established healthcare infrastructure and high awareness of antiretroviral therapies.

Competitive Analysis

Tipranavir competes with other protease inhibitors such as lopinavir, amprenavir, saquinavir, and indinavir. However, its nonpeptidic structure and efficacy against resistant strains give it a competitive edge in the market[5].

Market Projections

Forecast Period

The tipranavir market is expected to grow from 2025 to 2031, driven by increasing demand for effective antiretroviral therapies. The forecast period will see a steady increase in market size and revenue, with a notable compound annual growth rate (CAGR)[2].

Segment Analysis

The market can be segmented by formulation (capsules and oral solutions), by age group (adults and pediatrics), and by region. The oral solution formulation is expected to have a significant impact, particularly in pediatric care, due to its ease of administration and bioavailability[3].

Challenges and Opportunities

Despite its efficacy, the tipranavir market faces challenges such as the high incidence of adverse events, including gastrointestinal issues and liver enzyme elevations. However, the ongoing development of new formulations and the expanding global healthcare infrastructure present opportunities for growth.

Adverse Events and Safety Profile

Common Adverse Reactions

Clinical trials have identified several common adverse reactions associated with tipranavir, including diarrhea, nausea, vomiting, and elevations in liver enzymes and lipid levels. These reactions are more frequent when tipranavir is co-administered with ritonavir[4].

Serious Adverse Events

Rare but serious adverse events such as intracranial hemorrhage (ICH) have been reported. However, these events are not statistically significant and do not outweigh the benefits of treatment, especially in patients with multidrug-resistant HIV-1[3].

Regulatory Approvals

Accelerated Approval

Tipranavir received accelerated approval from the FDA on June 22, 2005, for the treatment of HIV-1 infection in highly treatment-experienced adult patients. This approval was based on the drug's efficacy in reducing viral load and increasing CD4 cell counts[5].

Postmarketing Surveillance

The FDA has mandated postmarketing risk management activities, including periodic safety reports and continued follow-up of pediatric patients enrolled in clinical studies[3].

Key Takeaways

• Efficacy: Tipranavir co-administered with ritonavir has demonstrated superior antiviral activity in treatment-experienced patients with multidrug-resistant HIV-1.
• Safety: Common adverse reactions include gastrointestinal issues and liver enzyme elevations, with rare but serious events like ICH.
• Market Growth: The tipranavir market is expected to grow from 2025 to 2031, driven by increasing demand for effective antiretroviral therapies.
• Formulations: Both capsule and oral solution formulations are available, enhancing the drug's appeal in various patient populations.
• Regulatory Status: Tipranavir received accelerated FDA approval in 2005 and is subject to ongoing postmarketing surveillance.

FAQs

What is the recommended dosage of tipranavir?

The recommended dose of tipranavir is 500 mg (two 250-mg capsules), co-administered with 200 mg of ritonavir, twice daily[4].

What are the common adverse reactions associated with tipranavir?

Common adverse reactions include diarrhea, nausea, vomiting, and elevations in liver enzymes and lipid levels[4].

Is tipranavir effective in pediatric patients?

Yes, tipranavir has been shown to be effective in pediatric patients aged 2 to 18 years, with the higher dose being more effective in older children with multiple baseline tipranavir-associated mutations[3].

What is the market outlook for tipranavir from 2025 to 2031?

The tipranavir market is expected to grow, driven by increasing demand for effective antiretroviral therapies, with a notable CAGR during the forecast period[2].

Are there any serious adverse events associated with tipranavir?

Rare but serious adverse events such as intracranial hemorrhage (ICH) have been reported, although these are not statistically significant and do not outweigh the benefits of treatment[3].

Sources

1. Clinical Infectious Diseases: "Efficacy of the Protease Inhibitors Tipranavir plus Ritonavir in Treatment-Experienced Patients Infected with Multidrug-Resistant Human Immunodeficiency Virus Type 1."
2. Cognitive Market Research: "Tipranavir Market Report 2024 (Global Edition)."
3. FDA: "Clinical Review of NDA 21-814, 21-822, 22-292 for APTIVUS (Tipranavir)."
4. FDA: "Label for APTIVUS (Tipranavir) Capsules and Oral Solution."
5. Managed Healthcare Executive: "Aptivus - Accelerated Approval Granted for Protease Inhibitor."