3 TPV/RTV Doses in Multiple ARV Experienced Patients - Tipranavir Dose Defining Study

Study Overview
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Brief Summary
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A dose defining study of the protease inhibitor tipranavir (TPV), boosted with low dose ritonavir (RTV). Three dose combinations of TPV/RTV are administered to multiple antiretroviral experienced patients and the dose that achieves the best efficacy and safety as determined by evaluation of 2, 8, and 24-week virologic response and adverse event and laboratory profile measures would be selected for further clinical study.

Official Title
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Double-blind, Randomized, Dose Optimization Trial of Three Doses of Tipranavir Boosted With Low Dose Ritonavir (TPV/RTV) in Multiple Antiretroviral Drug-experienced Subjects

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Tipranavir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Signed informed consent prior to trial participation. Human immunodeficiency virus 1 (HIV-1) infected males or females > 18 years of age. At least 3 months experience taking Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleoside reverse transcriptase inhibitor (NNRTIs), and Protease inhibitors (PIs). Current PI-based Antiretroviral (ARV) medication regimen for at least 3 months prior to randomization, and at least 3 months experience taking at least one other PI-based regimen. HIV-1 viral load ≥1000 copies/mL at screening. Genotypic resistance report indicating one or more primary PI resistance mutation(s), including 30N, 46I/L, 48V, 50V, 82A/F/T, 84V or 90M. Availability of 2 or more non-PI ARV medications by genotypic resistance testing, i.e. 2 drugs tested as no evidence of resistance or possible resistance. Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if severity is no higher than Grade 3 Gamma glutamyl transferase (GGT), Grade 2 cholesterol or triglycerides, and no higher than Grade 1 for all other tests based on the Division of Acquired Immune Deficiency Syndrome of National Institute of Health, USA - DAIDS - Grading Scale. All laboratory values outside these limits are subject to approval by Boehringer Ingelheim (BI). Further inclusion criteria apply. Exclusion criteria: ARV medication naïve. Only one or no available ARV medications as determined by genotypic resistance testing. Female subjects who: have a positive serum pregnancy test at screening or during the study; are breast feeding; are planning to become pregnant; are not willing to use two methods of contraception to include at least one barrier method (e.g. latex condom plus spermicidal jelly/foam). Any active opportunistic infection within 60 days before study entry. Active Hepatitis B (HCB) or Hepatitis C (HCV) disease defined as HBsAg positive or HCV RNA positive with Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > Grade 1. Prior tipranavir use. Use of investigational medications within 30 days before study entry or during the trial.Some expanded access drugs may be acceptable; must be approved by BI. Tenofovir, investigational at time of preparation of this protocol, is acceptable. Use of concomitant drugs which may significantly reduce plasma levels of the study medications. Further exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tipranavir|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic response after 2 weeks of functional monotherapy |  | At week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic response after 8 and 24 weeks of therapy and adverse event and laboratory safety measures. |  | Up to 24 weeks |