A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.

This study has been terminated.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00144105

Purpose

Successfully screened patients are randomised to open label TPV 500 mg with RTV 100 mg or 200 mg BID or open label LPV 400 mg with RTV 100 mg BID. Background ARV therapy is Tenofovir 300 mg + Lamivudine 300 mg QD in all three treatment groups. The randomisation is stratified by CD4 cell count > 200 cells/µL at screening. The duration of the treatment is 156 weeks.

Condition	Intervention	Phase
HIV Infections	Drug: TPV500mg/RTV200mgBID Drug: TPV500mg/RTV100mgBID Drug: LPV400mg/RTV100mgBID	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir Lopinavir Tipranavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	A Randomised, Open Label, Active Controlled Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir Plus 100 mg or 200 mg Ritonavir p.o. BID in Combination With Standard Background Regimen in Comparison to 400 mg Lopinavir Plus 100 mg Ritonavir p.o. BID in Combination

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint is the proportion of treatment responders at 48 weeks. A treatment responder is a patient with a viral load (VL) less than 50 copies/mL measured at two consecutive visits without prior rebound or change of ARV therapy.

Secondary Outcome Measures:

Further analyses to evaluate the primary endpoint at 24, 96, and 156 weeks. Secondary endpoints include proportion of patients with VL< 400 copies/mL, change from baseline in CD4+ cell counts at each visit, time to a new CDC class C progression event.

Estimated Enrollment:	540
Study Start Date:	February 2004
Estimated Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent prior to trial participation.
HIV-1 infected males or females >= 18 years of age.
No previous ARV therapy.
Any CD4+ T lymphocyte count < 500 cells / µl.
HIV-1 viral load >= 5000 copies/mL at screening.
Screening laboratory values that indicate adequate baseline organ function.
A prior AIDS defining event is acceptable as long as it has resolved or the subject has been on stable treatment (e.g. opportunistic infection; no ARV) for at least 2 weeks before screening

Exclusion criteria:

Female patients of child-bearing potential who:
- have a positive serum pregnancy test at screening or during the study,
- are breast feeding,
- are planning to become pregnant
Use of investigational medications within 30 days before study entry or during the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144105

Show 81 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Investigator:

Boehringer Ingelheim Study Coordinator

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	1182.33
Study First Received:	September 2, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00144105
Health Authority:	Unspecified

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Tipranavir

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009