The objective of this study is to demonstrate the safety and efficacy of TPV/r among a racially diverse HIV-positive population of females and males who are three-class (NRTI, NNRTI, and PI) experienced with a minimum of 3-months duration for each class and have documented resistance to more than one PI. Patients must be tipranavir-naïve and must have a viral load >=1000 copies/mL and a CD4+ cell count >50/mm3 in order to qualify for the study.
Conditions
Interventions
Trade Name: APTIVUS 250 mg soft capsules
Product Name: Aptivus 250 mg soft capsules
Pharmaceutical Form: Capsule, soft
Other descriptive name: Tipranavir
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-1 infected adults, men and women >=18 years of age. 2. Three-class (NRTI, NNRTI, and PI) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI (on the screening resistance testing). 3. CD4+ T lymphocyte count =50 cells/mm3. 4. HIV-1 viral load >=1,000 copies/mL at screening . 5. The ARV study treatment regimen must consist of new TPV/r in combination with an OBR of 2-4 agents of the following: N(t)RTIs (NRTI or NtRTI), enfuvirtide (ENF), and/or, where available, an Expanded Access Program (EAP) investigational agent (Section 3.3). In total, patients are to have an ARV study treatment regimen consisting of at least 3 agents (TPV/r and at least two OBRs). The following considerations must be applied in construction of the OBR: • At least one of the OBR agents must be new (defined as first time patient use). • If two N(t)RTIs are used for the OBR, at least one of the RTIs must be new to the patient with a “maximal response” on the Virco resistance analysis report. The other N(t)RTIs in the regimen may have either a “maximal or reduced response” on the Virco resistance analysis report. • If either new ENF and/or potentially approved new agents (e.g., raltegravir and maraviroc) are used for the OBR, the N(t)RTIs may have either a “maximal or reduced response” on the Virco resistance analysis report. Raltegravir and maraviroc may be accessed commercially if approved or through EAPs where available. • N(t)RTIs that are classified as having a “minimal or resistant response” on the Virco resistance analysis report may be used but will not count as one of the 2-4 active agents required to be in the OBR. • For patients who had previously taken lamivudine (3TC) or emtricitabine (FTC), neither of these drugs is considered as sensitive regardless of the genotype report. If previously taken, either 3TC or FTC may be included in the OBR but will not count as one of the 2-4 agents required to be in the OBR. Patients co-infected with HBV already treated at screening with anti-HBV drugs which have also an anti-HIV activity (lamivudine, emtricitabine, tenofovir) should remain on these drugs during the trial. These drugs, however, will not be counted as active anti-HIV drugs in the background regimen. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any of the ingredients to the tipranavir or ritonavir formulations. 2. ARV medication naïve. 3. Genotypic resistance to TPV (defined as a TPV mutation score >7). 4. Prior tipranavir use. 5. Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to demonstrate the safety and efficacy of TPV/r among a racially diverse HIV-positive population of females and males ;Secondary Objective: The objective of the TDM pilot evaluation of the study is to determine the potential utility of TDM in a diverse group of HIV-infected patients receiving TPV/r. ;Primary end point(s): The primary efficacy endpoint of the study is treatment response at Week 48. Treatment response is a confirmed virologic response, defined as a viral load <50 copies/mL at two consecutive measurements at least 5 days apart, without: ? Death, ? Permanent discontinuation of the study drug or loss to follow-up, or ? Introduction of a new antiretroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug , but not the study drug. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed