Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have not received previous HIV treatment or have received early treatment without TMC114 regimens.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Ltd.
• Treatments: Darunavir; Ritonavir

Criteria

Inclusion Criteria:

• Patients with documented HIV-1 infection who are ineligible for participation in any other Sponsor's HIV-1 trial

• Patients have never been treated with antiretroviral (ARV) medications or have prior early treatment-experienced without TMC114 regimens, including they have limited or no treatment options due to virological failure or intolerance to regimens

• Patient's general medical condition, in the investigator's opinion evaluating the patient is eligible for TMC114 containing regimen, does not interfere with the assessments and the completion of the trial

Exclusion Criteria:

• Any active clinically significant disease or findings during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the screening phase of the trial

• Evidence of active liver disease, acute viral hepatitis, liver impairment/dysfunction or cirrhosis irrespective of liver enzyme levels; however, patients coinfected with hepatitis B or C will be included if their condition is judged to be clinically stable

• Grade 3 or 4 laboratory abnormalities as defined by Division of AIDS (DAIDS).

• Calculated creatinine clearance (CrCl) less than 50 ml/min

• Female patients that are pregnant or breast-feeding, or of childbearing potential without using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last 30 days after the end of the treatment period

• Any condition (including but not limited to alcohol and/or drug abuse), which in the opinion of the investigator, could compromise the patient's safety or compliance to the study protocol procedures