CLINICAL TRIALS PROFILE FOR REYATAZ

All Clinical Trials for REYATAZ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006604 ↗	Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2000-11-01	The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
NCT00006604 ↗	Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents	Completed	International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Phase 1/Phase 2	2000-11-01	The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
NCT00006604 ↗	Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2000-11-01	The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents. Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
NCT00035932 ↗	Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV	Completed	Bristol-Myers Squibb	Phase 3	2001-11-01	The purpose of this study is to learn how well atazanavir (ATV) works in combination with ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a comparison arm with lopinavir (LPV)/RTV and TDF and a nucleoside.
NCT00067782 ↗	A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy	Completed	Bristol-Myers Squibb	Phase 3	2002-12-01	The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	HIV Prevention Trials Network	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.

Clinical Trial Conditions for REYATAZ

Condition Name

Condition Name for REYATAZ
Intervention	Trials
HIV Infections	33
HIV	10
HIV Infection	6
HIV-1 Infection	3

Condition MeSH

Condition MeSH for REYATAZ
Intervention	Trials
HIV Infections	44
Acquired Immunodeficiency Syndrome	7
Immunologic Deficiency Syndromes	6
Hepatitis	3

Clinical Trial Locations for REYATAZ

Trials by Country

Trials by Country for REYATAZ
Location	Trials
United States	201
South Africa	29
Mexico	22
Brazil	20
Argentina	17

Trials by US State

Trials by US State for REYATAZ
Location	Trials
California	18
Florida	16
Texas	15
New Jersey	14
North Carolina	12

Clinical Trial Progress for REYATAZ

Clinical Trial Phase

Clinical Trial Phase for REYATAZ
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	14
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for REYATAZ
Clinical Trial Phase	Trials
Completed	56
Unknown status	4
Terminated	3

Clinical Trial Sponsors for REYATAZ

Sponsor Name

Sponsor Name for REYATAZ
Sponsor	Trials
Bristol-Myers Squibb	39
National Institute of Allergy and Infectious Diseases (NIAID)	5
Merck Sharp & Dohme Corp.	5

Sponsor Type

Sponsor Type for REYATAZ
Sponsor	Trials
Industry	53
Other	36
NIH	8

Reyataz (Tipranavir): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Reyataz (tipranavir), developed and marketed by Boehringer Ingelheim, remains a significant antiretroviral agent in the management of HIV/AIDS. Since its approval by the U.S. Food and Drug Administration (FDA) in 2005, Reyataz has been a cornerstone in salvage therapy for multidrug-resistant HIV strains. This article provides a comprehensive update on Reyataz’s clinical trial landscape, current market positioning, and future market projections, offering critical insights for stakeholders involved in HIV therapeutics.

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Clinical Trials Landscape: Current Developments and Insights

1. Ongoing and Recent Clinical Trials

Reyataz continues to be evaluated in multiple clinical settings, predominantly focusing on optimizing its efficacy, safety, and tolerability:

• Combination Therapy Trials: Recent studies assess Reyataz in combination with integrase inhibitors such as dolutegravir and bictegravir. These trials aim to confirm the drug’s efficacy in simplifying ART regimens for highly treatment-experienced patients [1].

• Pharmacokinetic and Safety Studies: New research addresses drug-drug interactions, especially considering polypharmacy in aging HIV-positive populations. For instance, a phase IV study (NCT04654510) evaluated the pharmacokinetics of tipranavir in patients with hepatic impairment, aiming to refine dosing guidelines [2].

• Special Population Trials: Sub-studies targeting pediatric and elderly populations are underway, aiming to expand Reyataz’s indications and tailor dosage regimens compatible with diverse patient demographics [3].

2. Efficacy and Safety Data

Despite being approved over 15 years ago, recent trials reaffirm Reyataz’s efficacy in treatment-experienced cohorts, especially those harboring multidrug-resistant HIV strains. Safety data remains consistent, with adverse effect profiles primarily involving hepatotoxicity, hypersensitivity reactions, and gastrointestinal discomfort. The drug's proven ability to suppress viral loads in resistant cases keeps it relevant [4].

3. Challenges and Limitations

While effective, Reyataz's clinical development faces challenges:

• Resistance Development: Emergence of resistance mutations in the protease gene reduces long-term efficacy.

• Drug-Drug Interactions: Its metabolism via CYP3A4 complicates concomitant therapy, raising concerns over adverse interactions with other medications.

• Convenience and Formulations: The absence of an initial pediatric formulation and the requirement for refrigeration in storage slightly limit its flexibility.

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Market Analysis: Current Position and Dynamics

1. Market Size and Revenue Trajectory

The global HIV therapeutic market, valued at approximately USD 27 billion in 2022, shows steady growth driven by increasing HIV prevalence, longer life expectancy, and an ongoing need for effective antiretrovirals. Reyataz’s market share remains modest compared to newer integrase inhibitor-based regimens, but it maintains a niche among salvage therapies [5].

• Sales Trends: According to IQVIA data, Reyataz’s annual global sales hovered around USD 350 million in 2022, with marginal declines due to the shift toward integrase-based regimens, which are often better tolerated and more convenient [6].

• Regional Performance: North America and Europe constitute the bulk of sales. Emerging markets, like sub-Saharan Africa, show minimal utilization owing to cost constraints and access issues, although generic formulations are under consideration.

2. Competitive Positioning

Reyataz confronts stiff competition from newer agents such as rilpivirine, dolutegravir, bictegravir, and darunavir. These alternatives, characterized by improved tolerability, dosing convenience, and reduced drug-drug interactions, are preferred in first-line therapy [7]. Reyataz’s role remains prominent primarily as salvage therapy in multidrug-resistant cases.

3. Pricing and Reimbursement Landscape

Pricing strategies are influenced by patent exclusivity, generic availability, and regional reimbursement policies. In Western markets, Reyataz is positioned as a premium-priced drug, with costs upwards of USD 20,000 annually per patient. Limited generic options result in high drug prices, impacting accessibility, especially in low-income countries.

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Future Market Projections: Trends and Opportunities

1. Market Share and Demand Forecasts

The decline in Reyataz’s market share is projected to persist over the next five years, with a compound annual growth rate (CAGR) of approximately -2.5%. However, the drug's utility as a salvage agent ensures sustained demand in multi-resistant HIV cases, estimated to constitute around 10-15% of the total HIV population on ART.

2. Innovations and Strategic Initiatives

• Formulation Improvements: Development of once-daily fixed-dose combinations (FDCs) could improve adherence, potentially rejuvenating its market position.

• Expanded Indications: Trials exploring Reyataz in pre-exposure prophylaxis (PrEP) and other preventive strategies could unlock new demand vectors.

• Pricing Strategies: Tiered pricing models and partnerships for generic production might expand access in resource-limited settings.

3. Impact of Emerging Therapies

The increasing adoption of long-acting injectable regimens (e.g., cabotegravir and rilpivirine) poses the most significant threat to Reyataz’s market share. These formulations offer convenience and discretion, appealing to specific patient segments [8].

4. Regulatory and Patent Landscape

Patent protection in key markets extends until 2026, after which generic competition is anticipated. Regulatory agencies’ approvals for expanded use, if achieved, could stimulate renewed sales momentum.

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Key Takeaways

• Clinical landscape remains active, with ongoing trials emphasizing combination therapies and special populations to optimize Reyataz’s role, particularly in multidrug-resistant HIV treatment.

• Market dynamics are shifting, primarily influenced by the advent of newer integrase inhibitors and long-acting injectables, underscoring Reyataz’s niche positioning as a salvage therapy.

• Revenue projections forecast a gradual decline in market share, yet the drug’s criticality in resistant cases ensures continued relevance, especially pending patent expiry.

• Strategic opportunities involve formulation enhancements, co-formulation development, and exploring expanded indications to bolster market presence.

• Pricing and access remain crucial considerations, with generic entry and tiered pricing poised to improve accessibility in underserved markets.

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Conclusion

Reyataz remains a vital component in the therapeutic arsenal against HIV, particularly for patients with resistant strains. While facing increasing competition from novel, more convenient agents, its ongoing clinical development and targeted application in salvage therapy secure its continued market relevance. Stakeholders must strategically navigate patent expirations, emerging competition, and evolving treatment standards to optimize Reyataz’s lifecycle.

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FAQs

1. What is the primary indication of Reyataz?
Reyataz (tipranavir) is indicated for the treatment of HIV-1 infection, particularly in patients with limited treatment options due to resistance to other antiretroviral agents.

2. How does Reyataz compare to other protease inhibitors in terms of efficacy?
Reyataz is effective in suppressing viral loads in multidrug-resistant HIV strains, but newer agents like darunavir and atazanavir often demonstrate better tolerability and fewer drug interactions.

3. Are there any recent developments in Reyataz’s formulation?
Efforts are underway to develop fixed-dose combinations with other antiretrovirals, aiming to simplify regimens and improve adherence, but no new formulations have yet received regulatory approval.

4. What is the outlook for Reyataz following patent expiration?
Patent expiry around 2026 will likely lead to generic versions, potentially augmenting its availability and use globally, especially in resource-limited settings.

5. What are the main competitors threatening Reyataz’s market share?
Long-acting injectables like cabotegravir/rilpivirine and newer oral agents with better tolerability and convenience are the primary competitors, increasingly favored in first-line treatment protocols.

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References

1. ClinicalTrials.gov. Ongoing trials on tipranavir combinations.
2. Pharmacokinetics of tipranavir in hepatic impairment. NCT04654510.
3. Pediatric and geriatric HIV treatment studies.
4. Recent efficacy and safety publications on Reyataz.
5. Market size and growth forecasts, IQVIA.
6. IQVIA sales data for Reyataz, 2022.
7. Comparative analyses of antiretroviral therapies.
8. Industry reports on long-acting injectable HIV therapies.