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

NCT ID: NCT01702090

Last Updated: 2016-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-06-30

Brief 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.

Detailed Description

This is a single-treatment-group, open-label (patients and study personnel will know the identity of the treatments given), single-center study. The primary goal of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs, agents that are used to treat viral infections). This study is intended for HIV-1-infected patients who have not received previous HIV treatment (treatment-naive patients) or have received early treatment without TMC114 regimens and who are ineligible to participate in any other sponsored HIV-1 study. This study will monitor and evaluate the safety and efficacy of TMC114/r in combination with ARVs during the course of the study. Treatment with TMC114/r will be continued until virologic failure (the inability to achieve or maintain suppression of viral replication), treatment-limiting toxicity, loss to follow-up, study withdrawal, pregnancy, until discontinuation of TMC114 development or when TMC114 becomes reimbursable for treatment-naive patients or when TMC114 becomes commercially available for treatment-experienced patients.

Conditions

HIV-1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMC114/ritonavir

Group Type: EXPERIMENTAL

TMC114/ritonavir

Intervention Type: DRUG

TMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs.

Interventions

TMC114/ritonavir

TMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs.

Intervention Type: DRUG

Other Intervention Names

PI

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien-Ching Hung, MD and PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Taipei, , Taiwan

Countries

Taiwan

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3374&filename=CR100712_CSR.pdf

Early access to TMC114 in combination with low-dose ritonavir (tmc114/r) and other Antiretrovirals (AVRs) for treatment-naïve or TMC114-naïve, early treatment-experienced in HIV-1 infected patients.

Other Identifiers

TMC114HIV4073

Identifier Type: OTHER

Identifier Source: secondary_id

DRV-C-10-TW01-001

Identifier Type: OTHER

Identifier Source: secondary_id

CR100712

Identifier Type: -

Identifier Source: org_study_id