This randomized, placebo-controlled, double-blind trial will be conducted in HIV-1 infected patients who have experienced virological failure with at least one NNRTI-based HAART regimen. The treatment duration of the previous NNRTI-based HAART regimen must have been = 8 weeks.
Conditions
Interventions
Product Code: BILR 355 BS
Pharmaceutical Form: Tablet
CAS Number: 380378-81-4
Current Sponsor code: BILR 355 BS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation. 2. HIV-1 infected males or females = 18 years of age. 3. History of NNRTI–based HAART = 8 weeks and at least one, but not more than 3 NNRTI-associated resistance mutations by current genotype as identified in Appendix 10.4. 4. TPV/r or LPV/r susceptible 5. CD4+ T lymphocyte count = 100 cells/µl. 7. HIV-1 viral load = 2000 copies/mL at screening. 8. Karnofsky score = 70 (see Appendix 10.8) 9. Based on the antiviral resistance profile of the patient’s virus, the investigator must be able to construct a background HAART treatment regimen (OBR) such that the patient will receive 3 effective ARV drugs, in addition to his study medication. 10. Acceptable screening laboratory values (Visit 1) that indicate adequate baseline organ function. Laboratory values are considered to be acceptable if the following apply: • Absolute neutrophil count (ANC) >750/mm3 • Hemoglobin =10 g/dL • Platelet count >99,000/mm3 • AST, ALT , and alkaline phosphatase =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The following resistance mutations demonstrated at any time prior to starting trial therapy: V106A and/or Y188L 2. Female patients of child-bearing potential who: •have a positive serum pregnancy test at screening orduring the study, •are breast feeding, •are planning to become pregnant, •are not willing to use a barrier method of contraception. 3. Active Hepatitis B or C disease defined as HBsAg positive or HCV RNA positive with AST/ALT > DAIDS Grade 1 4. Acute/previous mycobacterial or invasive fungal infection requiring therapy or prophylaxis with drugs interfering with or significantly affected by the cytochrome P450 system (see Appendix 10.7) 5. Use of investigational medications within 30 days before study entry or during the trial. 6. Use of concomitant drugs that may significantly reduce plasma levels of the study medications. 7. Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g. interferon, cyclosporin, hydroxyurea, interleukin 2). 8. Patients currently treated with systemic anti-cancer chemotherapy 9. Inability to adhere to the requirements of the protocol, including active substance abuse, as defined by the investigator. 10. In the opinion of the investigator, likely survival of less than 12 months because of underlying disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to determine the antiviral activity by day 8, of two dose levels of BILR 355 BS + RTV or placebo +RTV in HIV-1 infected, NNRTI-experienced patients.;Secondary Objective: To determine the safety and tolerability of BILR 355 BS + Ritonavir over 7 days monotherapy followed by 28 days combination therapy with Tipranavir or Lopinavir based HAART-regimen.;Primary end point(s): The primary endpoint will be reduction in plasma HIV-1 RNA from baseline to day 8, expressed in log10 copies/mm3. A change in the selected PI (substitution of TPV/r by LPV/r and vice versa) or OBR is allowed only if the reason for change is due to toxicity or intolerance attributable to a background NRTI or T-20. Of note, only TPV/r and LPV/r are allowed as PI treatment in this study. | — |
Countries
Germany
Outcome results
None listed