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.
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ClinicalTrials.gov Identifier: NCT00144105 |
Recruitment Status
:
Terminated
First Posted
: September 5, 2005
Last Update Posted
: November 1, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: TPV500mg/RTV200mgBID Drug: TPV500mg/RTV100mgBID Drug: LPV400mg/RTV100mgBID | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 562 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 With Standard Background Regimen in Antiretroviral Therapy Naive Patients for 48 With Extension up to 156 Weeks |
Study Start Date : | February 2004 |
Actual Primary Completion Date : | November 2006 |

- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144105

OverallOfficial: | Boehringer Ingelheim Study Coordinator |
ClinicalTrials.gov Identifier: | NCT00144105 History of Changes |
Other Study ID Numbers: |
1182.33 |
First Posted: | September 5, 2005 Key Record Dates |
Last Update Posted: | November 1, 2013 |
Last Verified: | October 2013 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir |
Tipranavir Antiviral Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |