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PubMed2006

Ambulance officers' use of online clinical evidence.

BACKGROUND: Hospital-based clinicians have been shown to use and attain benefits from online evidence systems. To our knowledge there have been no studies investigating whether and how ambulance officers use online evidence systems if provided. We surveyed ambulance officers to examine their knowledge and use of the Clinical Information Access Program (CIAP), an online evidence system providing 24-hour access to information to support evidence-based practice. METHODS: A questionnaire was completed by 278 ambulance officers in New South Wales, Australia. Comparisons were made between those who used CIAP and officers who had heard of, but not used CIAP. RESULTS: Half the sample (48.6%) knew of, and 28.8% had used CIAP. Users were more likely to have heard of CIAP from a CIAP representative/presentation, non-users from written information. Compared to ambulance officers who had heard of but had not used CIAP, users were more likely to report better computer skills and that their supervisors regarded use of CIAP as a legitimate part of ambulance officers' clinical role. The main reasons for non-use were lack of access(49.0%) and training(31.4%). Of users, 51.3% rated their skills at finding information as good/very good, 67.5% found the information sought all/most of the time, 87.3% believed CIAP had the potential to improve patient care and 28.2% had directly experienced this. Most access to CIAP occurred at home. The databases frequently accessed were MIMS (A medicines information database) (73.8%) and MEDLINE(67.5%). The major journals accessed were Journal of Emergency Nursing(37.5%), American Journal of Medicine(30.0%) and JAMA(27.5%). CONCLUSION: Over half of ambulance officers had not heard of CIAP. The proportion who knew about and used CIAP was also low. Reasons for this appear to be a work culture not convinced of CIAP's relevance to pre-hospital patient care and lack of access to CIAP at work. Ambulance officers who used CIAP accessed it primarily from home and valued it highly. Lack of access to CIAP at central work locations deprives ambulance officers of many of the benefits of an online evidence system.

Adult↗

PubMedDate not supplied

Dentist participation in a public-private partnership to increase Medicaid participation and access for children from low income families.

The purpose of this research is to solicit feedback from dental society members involved in a program (Access to Baby and Child Dentistry, ABCD) to provide care for children receiving Medicaid benefits, and to gain an understanding of dentist participation. We investigated whether general dentists who were participants in ABCD were more fully integrated into the dental society profession and community, and whether they demonstrated greater interest in children. Dentists were stratified regarding ABCD participation and randomly selected to be interviewed (N = 40). The majority thought it appropriate for general dentists to care for very young children. Participants found fewer problems in fee levels in Medicaid, but there was no difference in an index of fees between the groups. Participants were no more active in the dental society, and few differences existed between the groups regarding other aspects of personal or professional life. Dentists participating in ABCD to improve access had a good experience and have positive views of the program. This may encourage other nonspecialist colleagues to participate in programs for children.

Attitude of Health Personnel↗

PubMed2004

Nurses' use of online clinical evidence.

BACKGROUND: The 'information explosion' presents a significant challenge to the nursing profession. One way to assist access to information is to provide electronic information resources at the point of care. A large-scale survey of nurses working in the public health system in New South Wales, Australia, was undertaken as part of a 2-year evaluation of the Clinical Information Access Program (CIAP). This is a website which provides 24 hour, online access to a range of evidence sources at the point of care. AIM: This paper reports a study to investigate factors influencing nurses' use of online evidence available at the point of care and to examine differences between nurses in different roles. METHOD: Nurses from 65 randomly selected hospitals were surveyed. A convenience sample representing 25% of nursing staff at these hospitals was sought. Eighty-four per cent of the survey quota was met and 3128 questionnaires were completed and returned. RESULTS: The results showed that 58% of nurses had heard of the CIAP and, of those, 70% had used the website's resources. Senior nurses had greater awareness and use than others. The most frequent reasons for use were to fill a knowledge gap and for personal education. Lack of training was the most frequently cited reason for not using the website. Use of online evidence, particularly amongst senior staff, was higher than reported in previous studies. CONCLUSION: Use of online evidence was associated with nursing role, and with managerial and organizational support. Diffusion of innovation theory can help to explain some of the patterns observed. The use and impact of online evidence should be interpreted in the context of nursing practice and culture.

Adult↗

PubMed1987

Integration of geriatric assessment into the community.

The integration of geriatric assessment into the community calls for more than effective communication. There should be a defined approach to comprehensive care, of which the assessment service is a regular part, and the assessment process should have a predictable influence on further care decisions. Three types of integrating approaches are described: the "recognized specialty" approach, which is typical of several other developed countries; the "consolidated model," such as the On Lok program in San Francisco; and the "brokerage" model, such as the ACCESS program in Rochester, New York. Each approach has strengths and limitations. We may expect further evolution toward fully integrated programs.

Aged↗

PubMed1999

Social support and service use among homeless persons with serious mental illness.

It has been widely hypothesized that persons with greater social support use fewer health care services, although previous studies have shown variable results. This study examines the relationship between levels of social support and formal service use among clients entering 18 community treatment programs for homeless persons with serious mental illness as part of the ACCESS demonstration project of the U.S. Center for Mental Health Services. Baseline and follow-up data on 1,828 clients entering the ACCESS program were used to evaluate the relationship between individual client socio-demographic and clinical characteristics, seven measures of social support, and levels of formal service use in this population. Three measures of social support were positively related to the use of outpatient medical services and one each to the use of substance abuse services and the total days of service use. Six out of seven measures of social support were positively related to the receipt of multiple services. It appears that social support is most strongly associated with improved access to an array of different services--a very important need among this population.

Adult↗

PubMed1995

Lessons from the Essential Access Community Hospital Program for rural health network development.

The Essential Access Community Hospital (EACH) Program is testing a concept for limited-service hospitals established under Medicare called the Rural Primary Care Hospital (RPCH). The program uses cost-based reimbursement and relaxed regulatory requirements to help low-volume rural hospitals shift emphasis from acute care to primary care and emergency services. RPCHs must form "horizontal" networks with larger hospitals and may form "vertical" arrangements with ambulatory service providers and practitioners. A small number of rural hospitals have converted to the RPCH status since the program entered the implementation stage in late 1993. It is unclear how many other hospitals will convert given uncertainty regarding the financial impact of RPCH conversion and concerns with certain requirements. The program illustrates how payment policies can provide incentives for network development and reflects the importance of physician involvement and technical assistance in developing limited-service hospitals. In addition, it appears that EACH/RPCH networks that form under the program may serve as building blocks for broader networks, as the seven states involved in the program look to develop rural health networks that go beyond the EACH/RPCH model.

Comprehensive Health Care↗

PubMed2005

Facilitating entry into drug treatment among injection drug users referred from a needle exchange program: Results from a community-based behavioral intervention trial.

We evaluated a case management intervention to increase treatment entry among injecting drug users referred from a needle exchange program (NEP). A randomized trial of a strengths based case management (intervention) versus passive referral (control) was conducted among NEP attenders requesting and receiving referrals to subsidized, publicly funded opiate agonist treatment programs in Baltimore, MD. Logistic regression identified predictors of treatment entry within 7 days, confirmed through treatment program records. Of 247 potential subjects, 245 (99%) participated. HIV prevalence was 19%. Overall, 34% entered treatment within 7 days (intervention: 40% versus control: 26%, p=0.03). In a multivariate "intention to treat" model (i.e., ignoring the amount of case management actually received), those randomized to case management were more likely to enter treatment within 7 days. Additional "as treated" analyses revealed that participants who received 30 min or more of case management within 7 days were 33% more likely to enter treatment and the active ingredient of case management activities was provision of transportation. These findings demonstrate the combined value of offering dedicated treatment referrals from NEP, case management and transportation in facilitating entry into drug abuse treatment. Such initiatives could be implemented at more than 140 needle exchange programs currently operating in the United States. These data also support the need for more accessible programs such as mobile or office-based drug abuse treatment.

Adult↗

PubMedDate not supplied

Medication use patterns and health outcomes among patients using a subsidized prescription drug program.

OBJECTIVE: To evaluate medication adherence, medication safety, health care utilization, and health outcomes among patients enrolled in a subsidized prescription program. DESIGN: Cross-sectional study. SETTING: Conducted as part of the Prescription Access program, a subsidized prescription program serving indigent patients residing in Franklin County, Ohio. PATIENTS: Patients qualifying for enrollment in the program were uninsured and had a household income of 200% or less of federal poverty level. Approximately 5% of the 2,500 patients (mean age, 70.6 years) enrolled in the program were systematically selected from a computer-generated patient enrollment report. INTERVENTION: Telephone interviews conducted by a pharmacist or advanced student pharmacist between January and September 2002. MAIN OUTCOME MEASURES: Patterns of medication use and safety, level of health care utilization, and health outcomes. RESULTS: A total of 104 patients reported taking a mean (+/- SD) of 6.7 +/- 3.8 medications. A total of 72 (69%) patients reported taking their medications correctly, and 90 (87%) reported finishing their medication course as prescribed. Medication refills were obtained by 75 (72%) patients, but of these patients, only 55 (73%) indicated that they obtained their refills on time. Adverse effects occurred in 25 (24%) patients, and 2 patients reported an allergic reaction. A total of 51 (49%) patients made unscheduled visits to their primary care physician, another health care facility, an emergency department, and/or were admitted to a hospital. Unscheduled visits occurred more often among nonadherent patients (59%) than adherent patients (44%), but not significantly so. In addition, 82 (79%) patients reported an improvement in health-related quality of life (QOL); 90 (87%) had a means of transportation to obtain medications; and 93 (89%) indicated that they would have to skip medications or give up necessities, if they were not enrolled in a subsidized prescription program. CONCLUSION: An improvement in self-reported QOL and a high rate of medication adherence demonstrate support for the benefits of this and similar subsidized prescription drug programs. A high rate of additional health care utilization, especially among nonadherent patients, indicates an area for further analysis, program revisions, and/or patient education.

Aged↗

PubMed2003

Iodine-131 Tositumomab: (131)I-anti-B1 antibody, (131)I-tositumomab, anti-CD20 murine monoclonal antibody-I-131, B1, Bexxar, (131)I-anti-B1 antibody, iodine-131 tositumomab, iodine-131 anti-B1 antibody, tositumomab.

Iodine-131 tositumomab [B1, Bexxar , iodine-131 anti-B1 antibody] is a murine antibody conjugated to iodine 131 that recognises and binds to the B1 (CD20) antigen which is found specifically on B lymphocytes. Iodine-131 tositumomab has a dual mechanism of action. It is capable of initiating a host immune response to those B cells to which it is attached, and it also triggers apoptosis in a significant proportion of the cells to which it binds. The product was first discovered by Coulter Corporation, Miami, in collaboration with the Dana-Farber Cancer Institute and the University of Michigan. The spin-off company Coulter Pharmaceutical, upon its formation, obtained worldwide rights to iodine-131 tositumomab. (Coulter Corporation was acquired subsequently by Beckman Instruments in October 1997. The union of the two companies produced Beckman Coulter.) In December 2000, Coulter Pharmaceutical was acquired by, and merged into, Corixa Corporation.Iodine-131 tositumomab is available for licencing in Japan. Corixa Corporation and GlaxoSmithKline signed an agreement to jointly develop and commercialise iodine-131 tositumomab. The total agreement has a potential value of up to $US132 million, plus shared profits and royalties. The two companies will jointly market the antibody in the US following regulatory approval. Corixa Corporation has announced it expects iodine-131 tositumomab to be approved in the US for non-Hodgkin's lymphoma (NHL). Under the terms of the original agreement, GlaxoSmithKline will receive exclusive marketing rights outside the US, excluding Japan. However, an amended agreement between the two companies will allow Corixa Corporation to also market the product outside the US. In February 2003, the European Commission granted iodine-131 tositumomab orphan-drug designation. Corixa Corporation and GlaxoSmithKline also intend to jointly investigate the use of the product in other indications. GlaxoSmithKline may also receive access to second generation anti-CD20 compounds under its agreement with Corixa Corporation. In May 2003, Corixa Corporation entered into an agreement that will see GlaxoSmithKline market Bexxar in Canada. Under the terms of the agreement, Corixa Corporation will manufacture and supply the product to GlaxoSmithKline, who will register, market and sell it in Canada. In October 2001, Amersham PLC, a supplier of medical equipment, announced that its Amersham Health unit had signed a marketing agreement with Corixa Corporation. The agreement allows Amersham Health to market iodine-131 tositumomab in Europe. Corixa Corporation formed agreements with Boehringer Ingelheim Pharma KG and Lonza Biologics to produce the B1 antibody and radiolabelling of the antibody has been contracted out to MDS Nordion.Iodine-131 tositumomab has received orphan drug and fast track designation for the treatment of NHL. Corixa Corporation submitted a Biologics Licence Application (BLA) to the US FDA in 1999, seeking permission to market Bexxar in the US for the treatment of relapsed or refractory, low grade or transformed low grade B-cell NHL. Following a priority review, the US FDA requested that Corixa Corporation reformat certain sections and perform additional analyses of existing data in its BLA. Corixa Corporation and GlaxoSmithKline resubmitted their BLA to the US FDA in September 2000. The BLA was subsequently accepted by the US FDA in November 2000. However, in March 2001, the US FDA requested additional information in its complete review letter to Corixa Corporation and marketing partner GlaxoSmithKline. The two companies submitted data pertaining to the chemistry, manufacturing and controls section of the BLA, and to the majority of the questions regarding the clinical section of the BLA in August 2001. Corixa Corporation and GlaxoSmithKline submitted the remainder of the response to the US FDA in September 2001, following an independent review of clinical trial data. In March 2002, Corixa Corporation received another complete review letter from the US FDA, which stated that additional clinical trials would have to be conducted in order to provide adequate evidence of the safety and clinical benefit of Bexxa. The US FDA also denied Corixa Corporation's request for accelerated approval, stating that the data provided was inadequate to show that Bexxar filled an unmet medical need. Corixa Corporation has met formally with the US FDA but the two were unable to resolve their differences. Corixa Corporation will now file a formal request for dispute resolution under the Food and Drug Administration Modernisation Act. Corixa Corporation also requested a presentation of Bexxa data to the US FDA's scientific advisors. In June 2002, the US FDA granted the company's appeal for additional regulatory review. In December 2002, the US FDA's Oncologic Drugs Advisory Committee agreed that Bexxar has clinical benefit for patients with NHL. In May 2003, Corixa Corporation and GlaxoSmithKline announced that they had fulfilled many of the steps required for US FDA approval, however the US FDA has extended its review of the application for another 3 months. This extension will allow for further refinement of post marketing commitments and package insert language, and to ensure they are consistent with an updated safety database requested by the US FDA and submitted by Corixa Corporation in early April. GlaxoSmithKline was waiting for the outcome of the situation before deciding on marketing plans for Bexxar. Corixa Corporation and GlaxoSmithKline will conduct a head-to-head study of Bexxar and Idec's Zevalin, planned for mid-2003. The trial will likely be one of three phase IV studies that the US FDA requires for accelerated approval of Bexxar. Corixa Corporation initiated its Expanded Access Program for Bexxar in response to requests from physicians and patients for continued access to Bexxar during the period prior to potential US FDA marketing approval.A phase II multicentre trial of Bexxar in combination with CHOP chemotherapy is underway in the US as first-line therapy in patients with intermediate-grade NHL. Corixa Corporation has initiated a phase II trial of iodine-131 tositumomab in combination with cyclophosphamide, vincristine and prednisone for the treatment of previously untreated low-grade NHL. The trial was initiated while the company was preparing its BLA for Bexxar for use as a single agent for relapsed or refractory NHL. Corixa Corporation intends to pursue additional trials to expand the potential use of iodine-131 tositumomab to other indications, including chronic lymphocytic leukaemia. The agent is also in a clinical trial for preparation in autologous bone marrow transplant patients. The trial is designed to test the combination of iodine-131 tositumomab and chemotherapy. The trial began in 1995 and has so far enrolled 40 patients. In addition, a phase II dose-escalation trial has begun at the University of Nebraska for the combined use of iodine-131 tositumomab and chemotherapy as preparation for autologous bone marrow transplant. Corixa Corporation has received an issued US patent covering methods for administering and dosing radioimmunotherapy for the treatment of B-cell lymphomas. The patent covers iodine-131 tositumomab and other anti-CD20 antibodies used to aid in selective tumour targeting. Corixa Corporation has exclusive rights to the patent.A February 2000 media release from GlaxoSmithKline and Corixa Corporation stated that they had been issued a composition patent relating to radiolabelled monoclonal antibodies (including Bexxar) for the treatment of B-cell lymphomas. On 11 September 2001, IDEC announced that it had filed two separate lawsuits. The first lawsuit is against Corixa Corporation and the University of Michigan on six patents pertaining to products and processes related to radioimmunotherapy. They seek a declaration that Zevalin does not infringe Corixa Corporation's issued US patents. The second lawsuit involves two patents relating to cell culture media, and is against GlaxoSmithKline. IDEC's lawsuit in this case, seeks a declaration that its manufacture of Zevalin does not infringe GlaxoSmithKline's issued US patents. Corixa Corporation and GlaxoSmithKline have also filed a complaint for patent infringement against IDEC. These actions however, should have no effect on the regulatory process that Zevalin is completing, or prevent IDEC from launching the drug before iodine-131 tositumomab.A year earlier, in March 2001, the Financial Times reported that Bexxar could reach peak sales of $US120 million. In 1998, Coulter Pharmaceutical received a licencee fee payment of $US34 million from SmithKline Beecham (now GSK) in the fourth quarter of the year, as part of the joint development and commercialisation agreement for Bexxar.

Adjuvants, Immunologic↗

PubMed1998

Using incarceration rates to measure mental health program performance.

This article introduces a more refined conceptualization of the criminal justice involvement of clients of mental health programs than is evident in the existing literature, and demonstrates a research methodology that provides program administrators with standardized measures of program performance in this area. The conceptualization of the criminal justice involvement of people served by community mental health programs distinguishes between three distinct areas of concern: (1) program accessibility to people with a history of criminal justice involvement, (2) criminal justice outcomes, and (3) quality of program performance. The methodology makes use of existing data resources to provide a valid and reliable measure of program performance in these three areas.

Adult↗

PubMed2005

Meanings of targeting from program workers.

Program workers have a critical role in targeting in nutrition programs, but little has been studied about the concept and the operation of targeting from their perspectives. This paper introduces and compares meanings of targeting from the perspectives of program workers in food assistance programs in the United States. There exist some variations in perceptions of targeting and actual operational procedures adopted by program workers at the local and federal levels. Regardless, program workers' perspectives on targeting suggest a new framework of targeting, which consists of key components (program access, service, and evaluation) and issues in need of careful attention in targeting nutrition programs. The success of targeting depends on how well these components and related issues can be translated into targeting policy, rules, and procedures. With increased devolution to the state and local levels in the United States, it is even more critical for federal policy makers and administrators to understand how frontline program workers perceive and implement targeting. The new framework based on the perspectives of program workers may contribute to developing a conceptual definition as well as practical guidance for targeting that can be used to formulate better ways of targeting in nutrition programs.

Aged↗

PubMed1999

Access to "Jiggasha program: a family planning communication approach" and its exposure to the selected background characteristics.

Explore the source record for details and available documents.

Asia↗

PubMed2004

PDBSiteScan: a program for searching for active, binding and posttranslational modification sites in the 3D structures of proteins.

PDBSiteScan is a web-accessible program designed for searching three-dimensional (3D) protein fragments similar in structure to known active, binding and posttranslational modification sites. A collection of known sites we designated as PDBSite was set up by automated processing of the PDB database using the data on site localization in the SITE field. Additionally, protein-protein interaction sites were generated by analysis of atom coordinates in heterocomplexes. The total number of collected sites was more than 8100; they were assigned to more than 80 functional groups. PDBSiteScan provides automated search of the 3D protein fragments whose maximum distance mismatch (MDM) between N, Calpha and C atoms in a fragment and a functional site is not larger than the MDM threshold defined by the user. PDBSiteScan requires perfect matching of amino acids. PDBSiteScan enables recognition of functional sites in tertiary structures of proteins and allows proteins with functional information to be annotated. The program PDBSiteScan is available at http://wwwmgs.bionet.nsc.ru/mgs/systems/fastprot/pdbsitescan.html.

Binding Sites↗

PubMed2003

Interdisciplinary, web-based, self-study, interactive programs in the dental undergraduate program: a pilot.

The goal of this project was to encourage interdisciplinary, integrative health teaching and research in dental education through the development of web-accessible programs, collectively called the "StudyWeb." The specific objective of the project was the construction and integration of a series of prototypes of self-study modules. Four pilot modules were developed using existing teaching materials in histology, pharmacology, prosthodontics, and oral radiology and utilizing a variety of widely available software programs, including FrontPage and Photoshop. Low-end technological choices were made in order to facilitate compatibility with a wide range of hardware, software, and types of Internet access. Modules were tested for functionality, usability, and ease of navigation. The scope of the initial project was limited to development and functionality testing of the original modules. The next phase of this project will involve testing of the effectiveness of these web-based self-instruction tools.

Computer Systems↗

PubMed2005

Use of point-of-care online clinical evidence by junior and senior doctors in New South Wales public hospitals.

BACKGROUND: The Clinical Information Access Program (CIAP), an online evidence retrieval system, provides NSW health professionals in public hospitals with 24 h access to information supporting evidence-based practice. AIM: To assess the frequency and type of CIAP usage by senior and junior medical staff and doctors' attitudes to CIAP. METHODS: A convenience sample of 25% of doctors from 65 randomly selected public hospitals completed a survey. Junior (n = 392) and senior (n = 684) doctors' responses were compared using chi2 analyses and t-tests. RESULTS: Most doctors had heard of CIAP (71.8%) and 60.6% had used it. More junior (72.4%) than senior (53.8%) doctors had used CIAP and junior doctors found it easier to use. Of the users 93.5% believed CIAP had the potential to improve patient care; 55.2% had directly experienced this. Most usage (61.5%) occurred at point-of-care; 74% of users found all/most of the information they sought and 71.6% found the search time to be 'good/excellent'. Users had increased their usage in the past year and predicted increased future usage. The most popular databases were Medline and MIMS. Age, access to other evidence, and lack of training, time and computer skills were associated with non-usage. Junior and senior users differed in 4 of 15 reasons for using CIAP. CONCLUSIONS: CIAP is used and valued by the majority of doctors. Patterns of usage, online experiences and the attitudes toward CIAP of senior doctors who use CIAP are relatively similar to those of junior doctors.

Adult↗

PubMed2004

Outpatient medication assistance program in a rural setting.

PURPOSE: Efforts to provide medication assistance to the rural poor in central Louisiana are described. SUMMARY: The Central Louisiana Medication Access Program (CMAP) began functioning in 2001 with the objective of providing medication assistance and medication education to the rural poor in the community. The program serves individuals who use the outpatient clinic at the state-run public hospital in central Louisiana. Patients receive prescription drugs for a variety of chronic conditions, paying only a processing fee of dollar 3 per prescription, with a maximum outlay of dollar 15 per visit. A pharmacist counsels the patients about their medications. The medications are funded both through the program and through assistance programs run by pharmaceutical companies. A total of 5307 patients were enrolled in the CMAP between May 2001 and March 2003, and they received over 140,000 prescriptions at a cost saving to them in excess of dollar 2.5 million. CONCLUSION: The CMAP has been able to provide prescription medications and medication counseling to needy patients in a rural environment at little cost to them.

Adult↗

PubMed1989

Family ecology and child characteristics that predict young children's educational television viewing.

This study investigated how sociological variables, program access, family attributes, and child characteristics influence children's viewing of the most well-established educational television program in the United States--"Sesame Street." 2 cohorts were followed from ages 3 to 5 and 5 to 7, respectively. Each family kept a diary of television viewed during 5 1-week periods over 2 years. Interviews and testing sessions were conducted before and after the 2-year period. "Sesame Street" viewing increased from age 3 to a peak between the ages of 3 1/2 and 4; thereafter, viewing declined. This developmental change appeared to be a function of age-correlated life events and perceived age appropriateness of the program rather than of ontogenetic cognitive change. Individual differences were primarily a function of family ecology--opportunities to view and characteristics of other viewers--rather than of family demographics or individual child attributes. Maternal employment and the amount of time children attended child care or preschool were negatively related to viewing. The presence of older siblings reduced viewing; the presence of younger siblings increased it. Viewing was unrelated to parent education or occupational status, child gender, child's vocabulary level, involvement in television, or interest in print and other media. Parental encouragement to watch the program was positively related to viewing for 3-5-year-olds.

Age Factors↗

PubMed2006

Tipranavir: PNU 140690, tipranivir.

Tipranavir [PNU 140690, tipranivir, Aptivus] is a second-generation HIV dihydropyrone (a sulphonamide derivative), nonpeptidic protease inhibitor (NPPI) discovered by Pharmacia & Upjohn (now Pfizer) in the US. The compound is in development with Boehringer Ingelheim. Tipranavir has potent in vitro activity against a variety of HIV-1 laboratory strains and clinical isolates, including those resistant to ritonavir, as well as HIV-2. Tipranavir has been shown to act synergistically with other antiretroviral agents. The limited bioavailability of the hard gel (and first available) formulation of tipranavir led to the development of a soft capsule formulation that has better oral bioavailability. Pharmacia Corporation (now Pfizer) considers that the resistance profile of tipranavir may be sufficiently unique for it to be effective against protease inhibitor resistant virus. On 16 April 2003, Pharmacia Corporation was acquired by, and merged into, Pfizer. In February 2000, Boehringer Ingelheim acquired exclusive worldwide rights to tipranavir. Tipranavir was launched in the US in mid-2005. In June 2005, the US FDA granted accelerated approval to tipranavir capsules for use in combination treatment, based on 24-week data from ongoing clinical trials. The approved dose is Aptivus 500 mg taken with ritonavir 200 mg, twice daily. Aptivus 250 mg soft gel capsules are expected to be available in the second half of 2005. A submission was made to the FDA in October 2004 seeking accelerated approval. In May 2005, the Antiviral Drugs Advisory Committee of the FDA recommended the approval of tipranavir. The positive recommendation is based on data from the RESIST-1 and RESIST-2 studies. Also in October 2004, Boehringer Ingelheim submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for tipranavir for the treatment of HIV-1 infection in combination with other antiretroviral agents in patients who are protease inhibitor experienced. In July 2005, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for tipranavir in the European Union. If approved, the drug will be marketed in Europe too under the name Aptivus. Marketing authorisation under exceptional circumstances (accelerated approval) is expected before the end of 2005.A phase III clinical programme (RESIST- Randomised Evaluation of Strategic Intervention in Multi-drug ReSistant Patients with Tipranavir) was launched by Boehringer Ingelheim in February 2003. The RESIST programme consists of two phase III pivotal trials (RESIST 1 and RESIST 2) and two companion trials (study 1182.51 and RESIST 3) available at some sites for even more advanced patients. The trials are designed to further study the efficacy and safety of tipranavir (500 mg) boosted with low-dose (200 mg) ritonavir, taken twice daily, versus a low-dose ritonavir boosted comparator protease inhibitor that is chosen by the patient's physician on the basis of the treatment history and baseline resistance testing. Each patient will also receive an individualised background regimen. Study participants will all be highly treatment-experienced HIV-positive adults. RESIST 1 study enrolled 620 patients in the US, Canada and Australia and RESIST 2 enrolled more than 863 patients in Europe and South America. These trials are now fully recruited. The clinical endpoint for RESIST 1 is at 24 weeks and for RESIST 2, the endpoints are at 16 and 24 weeks. Interim data from RESIST 1 (1182.12) were presented at the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, DC, USA, in October 2004. Results from this study show that tipranavir is a viable treatment option for patients who have failed other protease inhibitors. In June 2004, Boehringer Ingelheim announced the expansion of enrolment criteria in the international Compassionate Use Programme to allow broader access to tipranavir for HIV patients in need of new treatment options. All countries participating in the tipranavir phase III programme are eligible to take part in the Compassionate Use programme, which is enrolling patients over the age of 18 years, who are triple-antiretroviral class-experienced with at least two PI-based regimens. In November 2004, Boehringer Ingelheim opened the tipranavir Expanded Access Program (EAP) in the US, following a review of the protocol by the FDA. The programme will provide access to tipranavir for HIV-infected patients (> or =18 years old) who are not enrolled in the ongoing tipranavir clinical studies and who are triple-antiretroviral class-experienced with at least two previous PI-based regimens, and have documented PI-resistance and need tipranavir to construct a viable treatment regimen. Eligibility is not dependent upon viral load or CD4+ cell count. Tiparanvir is also being evaluated in phase II studies for use in paediatric and treatment-naive patient populations. Phase II trials completed in the US have established the clinical activity of tiprananvir in both antiretroviral-naive and -experienced patients with HIV infection. The studies have also shown that tipranavir can be combined with ritonavir for maximal clinical benefit. In its 2003 Annual Report, Boehringer Ingelheim stated that the process- and paediatric- formulation development of tipranavir had been completed.

Clinical Trials as Topic↗