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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

HIV Infections

Treatments

Drug: Tipranavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00275444

1182.52

Details and patient eligibility

About

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.

Enrollment

216 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.