CLINICAL TRIALS PROFILE FOR APTIVUS

All Clinical Trials for Aptivus

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00146328 ↗	Rollover Trial Safety and Tolerability of Combination Tipranavir and Ritonavir Use in HIV 1 Infected Subjects	Completed	Boehringer Ingelheim	Phase 2/Phase 3	2001-04-01	The objective of this study is to determine the long term safety and tolerability of multiple oral doses of tipranavir (Aptivus) and ritonavir with a focus on the long term safety of the development dose (500 mg tipranavir/200 mg ritonavir BID) when administered with other antiretroviral medications.
NCT00344123 ↗	Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects	Completed	Boehringer Ingelheim	Phase 1	2007-02-01	Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
NCT00344123 ↗	Pharmacokinetic (PK) Study of Single-dose Rosuvastatin and Tipranavir/Ritonavir in Healthy Subjects	Completed	Johns Hopkins University	Phase 1	2007-02-01	Tipranavir (TPV) plus ritonavir (RTV) is indicated for use as part of an antiretroviral treatment regimen for resistant HIV-1 infection in adult patients. Since significant cholesterol and triglyceride elevations are commonly reported during TPV/RTV treatment, effective treatment strategies are critical to prevent long-term cardiovascular events. Rosuvastatin, a potent 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitor, is unlikely to interact with TPV/RTV since it is not extensively metabolized, however, a formal drug interaction study is needed before this combination can be recommended. This study will examine the pharmacokinetic interactions between tipranavir/ritonavir (TPV/RTV [TPV/r] 500 mg/200 mg twice daily [B.I.D]) and single dose rosuvastatin when the two are co-administered to healthy adult volunteers. The investigators hypothesize that if tipranavir 500 mg is co-administered with low-dose ritonavir 200 mg and rosuvastatin (10 mg) no significant clinical interaction will occur.
NCT00517192 ↗	Comparison of TPV/r to DRV/r in Triple Class Experienced Patient With Resistance to > 1 PI	Terminated	Boehringer Ingelheim	Phase 3	2007-09-01	The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.
NCT00531206 ↗	Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.	Completed	Boehringer Ingelheim		2006-08-01	This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.

Clinical Trial Conditions for Aptivus

Condition Name

Condition Name for Aptivus
Intervention	Trials
HIV Infections	7

Condition MeSH

Condition MeSH for Aptivus
Intervention	Trials
HIV Infections	7
Infections	1
Infection	1
Communicable Diseases	1

Clinical Trial Locations for Aptivus

Trials by Country

Trials by Country for Aptivus
Location	Trials
United States	39
Canada	6
Germany	3
France	3
Spain	2

Trials by US State

Trials by US State for Aptivus
Location	Trials
California	3
Maryland	3
Texas	2
North Carolina	2
New York	2

Clinical Trial Progress for Aptivus

Clinical Trial Phase

Clinical Trial Phase for Aptivus
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Aptivus
Clinical Trial Phase	Trials
Completed	6
Terminated	1

Clinical Trial Sponsors for Aptivus

Sponsor Name

Sponsor Name for Aptivus
Sponsor	Trials
Boehringer Ingelheim	6
Johns Hopkins University	1
National Institute of Mental Health (NIMH)	1

Sponsor Type

Sponsor Type for Aptivus
Sponsor	Trials
Industry	6
Other	2
NIH	2

Clinical Trials and Efficacy of Aptivus

Introduction to Aptivus

Aptivus, also known as tipranavir, is a non-peptidic protease inhibitor developed by Boehringer Ingelheim for the treatment of HIV-1 infection. It is specifically indicated for use in combination antiretroviral therapy for treatment-experienced patients who have developed resistance to other protease inhibitors.

Clinical Trials in Adults

The efficacy of Aptivus was evaluated in two main clinical studies involving a total of 1,483 adults who had received multiple HIV treatments in the past and were not responding to their current treatment regimens. These studies compared Aptivus, co-administered with ritonavir, to other protease inhibitors chosen based on the patients' previous treatments and predicted response.

• Response Rates: In these studies, 34% of the patients taking Aptivus (251 out of 746) achieved a viral load reduction of 90% or more, maintained until the end of the 48-week period. In contrast, only 16% of the patients taking the comparator protease inhibitors (113 out of 737) achieved this level of response[1][3][4].

• Duration of Response: The treatment with Aptivus and ritonavir showed a longer duration of response compared to the comparator treatments. On average, it took 113 days for the treatment to stop working in adults taking Aptivus, whereas most patients taking the comparator did not respond at all[1].

Clinical Trials in Pediatric Patients

Aptivus was also studied in pediatric patients in an open-label study involving 63 children aged 2-12 years and 52 adolescents aged 12-18 years. All patients had previously taken HIV treatments.

• Viral Load Reduction: In this study, 50% of the children (31 out of 62) and 31% of the adolescents (9 out of 29) achieved and maintained viral loads below 400 copies/ml after 48 weeks[1].

Safety and Adverse Reactions

The clinical trials highlighted several adverse reactions associated with Aptivus when co-administered with ritonavir. Common adverse reactions included diarrhea, nausea, pyrexia, vomiting, fatigue, headache, and abdominal pain. The 48-week Kaplan-Meier rates of adverse reactions leading to discontinuation were 13.3% for Aptivus/ritonavir-treated patients and 10.8% for the comparator arm patients[4].

Market Analysis and Approval

Regulatory Approval

Aptivus received full marketing authorization from the European Commission and the U.S. FDA for use in highly treatment-experienced adult HIV patients. Initially approved under "exceptional circumstances," the European Commission later dropped this clause, allowing broader prescription of the drug[3].

Market Potential and Challenges

Despite its efficacy, the adoption of Aptivus may be slow in some markets due to its high price and varying reimbursement status across countries. Boehringer Ingelheim is pursuing additional clinical trials to assess Aptivus's efficacy in different patient populations, including specific ethnic groups and children, which could extend its approved indications[3].

Market Projections

Current Market Position

Aptivus is positioned as a last-line therapy for patients who have exhausted other treatment options. Its use is recommended when no other protease inhibitors are predicted to work. This niche positioning ensures a dedicated market segment but also limits its broader market potential[1][3].

Future Clinical Trials and Indications

Boehringer Ingelheim is conducting follow-on trials from the RESIST program to further evaluate Aptivus's efficacy. Encouraging results from these trials could lead to extended approved indications, potentially increasing its market reach and patient population[3].

Economic and Healthcare Impact

Cost and Reimbursement

The high cost of Aptivus and the variability in reimbursement policies across different countries can affect its prescribing rates. However, the drug's efficacy in treating highly treatment-experienced patients makes it a valuable option for those with limited alternatives[3].

Healthcare System Impact

Aptivus's approval and use contribute to the broader antiretroviral treatment landscape, providing a critical option for patients who have developed resistance to other treatments. This helps in managing the HIV epidemic more effectively, especially in cases where other treatments have failed[1][3].

Key Takeaways

• Efficacy: Aptivus, co-administered with ritonavir, has shown significant efficacy in reducing viral loads in treatment-experienced HIV patients.
• Safety: The drug is associated with several adverse reactions, but its benefits outweigh the risks for patients with limited treatment options.
• Market Position: Aptivus is approved as a last-line therapy, targeting a specific segment of the HIV treatment market.
• Future Prospects: Ongoing and planned clinical trials may extend its approved indications, potentially increasing its market reach.

FAQs

What is Aptivus used for?

Aptivus (tipranavir) is used in combination antiretroviral therapy for the treatment of HIV-1 infection in treatment-experienced patients who have developed resistance to other protease inhibitors[1][3][4].

How effective is Aptivus in clinical trials?

In clinical trials, Aptivus co-administered with ritonavir showed a higher response rate compared to other protease inhibitors, with 34% of patients achieving a viral load reduction of 90% or more[1].

What are the common adverse reactions associated with Aptivus?

Common adverse reactions include diarrhea, nausea, pyrexia, vomiting, fatigue, headache, and abdominal pain[4].

Is Aptivus approved for pediatric use?

Yes, Aptivus is approved for use in children aged 2-12 years as an oral solution and in adolescents aged 12-18 years as capsules, following a study that showed its safety and efficacy in these age groups[1].

What are the future prospects for Aptivus?

Boehringer Ingelheim is conducting additional clinical trials to assess Aptivus's efficacy in different patient populations, which could lead to extended approved indications and increased market reach[3].

Sources

1. European Medicines Agency (EMA). Aptivus | European Medicines Agency (EMA).
2. CoinUnited.io. Biggest Aptiv PLC (APTV) Trading Opportunities in 2025.
3. S&P Global Market Intelligence. EU Nod Sees Boehringer Ingelheim's Aptivus Gain Wider Potential.
4. FDA. APTIVUS (tipranavir) Label - accessdata.fda.gov.

Last updated: 2025-01-07