Safety, efficacy and Pharmacokinetics of tipRanavir boosted with low-dose ritonavir TPV/r 500 mg/200 mg BID IN a racially and Gender diverse HIV-positive treatment experienced population with a pilot evaluation of therapeutic drug monitoring TDM . The SPRING study is an open-label, multicenter, multinational trial with randomisation to standard of care SOC or TDM TPV/r therapy - SPRING

• Conditions: MedDRA version: 9.1Level: HLTClassification code 10052740Term: Acquired immunodeficiency syndromes; 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.

• Registration Number: EUCTR2005-005264-86-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

-HIV-1 infected males or females 18 years of age. -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 . -CD4 T lymphocyte count 50 cells/mm 3. -Patients must have at least one of the following permutations of ARV medications available and must be willing to use them in the OBR for trial inclusion 1 Two genotypically active reverse transcriptase inhibitors RTIs as defined as two drugs that are reported as sensitive in the genotype report. 2 One genotypically active RTI reported as sensitive in the genotype report and enfuvirtide if not used previously. For patients who had previously taken 3TC lamivudine or FTC emtricitabine , these drugs are not considered as sensitive regardless of the genotype report. -The four AIDS defining events listed below are acceptable as long as the event has been cured for at least 2 weeks before screening Visit 1 . Patients with a history of other AIDS defining events are not allowed into the trial. The acceptable prior AIDS defining events include Candidiasis bronchi, trachea, lungs, esophageal Herpes simplex chronic ulcer s 1 month s duration , bronchitis, pneumonitis, or esophagitis Mycobacterium tuberculosis pulmonary or extrapulmonary Pneumonia including Pneumocystis jiroveci formerly carinii pneumonia.
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

-Known hypersensitivity to any of the ingredients in the tipranavir and ritonavir formulations. -ARV medication na ve. -Genotypic resistance to tipranavir defined as a TPV mutation score 7 . -Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the month prior to screening. -Female patients of childbearing potential who have a positive serum pregnancy test at screening or entry are breast feeding are planning to become pregnant are not willing to use barrier method contraception are only willing to use an estrogen-containing medication, e.g., ethinyl estradiol, as a method of contraception -Prior tipranavir use. -Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the safety and efficacy of TPV/r among a racially diverse HIV-positive treatment experienced population of females and males.;Secondary Objective: To determine the potential utility of TDM in a diverse group of HIV-infected patients receiving TPV/r.;Primary end point(s): The primary endpoint is treatment response at Week 48. Treatment response is a confirmed virologic response, defined as a viral load 50 copies/mL at two consecutive VL measurements at least 5 days apart, without death, permanent discontinuation of 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.