Early Access to TMC114/r and Other AVT for Treatment-naive or Early Treatment Experienced in HIV-1 Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier:
NCT01702090
First received: February 13, 2012
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
HIV-1
Drug: TMC114/ritonavir
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Access to TMC114 in Combination With Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or TMC114-naive, Early Treatment Experienced in HIV-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.:

Primary Outcome Measures:
  • Change in plasma HIV-1 RNA level [ Time Frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months ] [ Designated as safety issue: No ]
    End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.

  • Change in plasma CD4 cell count [ Time Frame: Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months ] [ Designated as safety issue: No ]
    End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.


Secondary Outcome Measures:
  • Number of participants affected by an adverse event [ Time Frame: Up to end-of-study visit, an expected average of approximately 3 months ] [ Designated as safety issue: Yes ]
    End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.


Enrollment: 10
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TMC114/ritonavir Drug: 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.
Other Name: PI

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 Tibotec-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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with documented HIV-1 infection who are ineligible for participation in any other Tibotec-sponsored HIV-1 trial
  • Patients have never been treated with antiretroviral (ARV) medications or having prior early treatment-experienced without TMC114 regimens, including they are have limited or no treatment options due to virological failure or intolerance to regimens
  • Patient's general medical condition, in the investigator's opinion that 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702090

Locations
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
Principal Investigator: Chien-Ching Hung, MD and PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT01702090     History of Changes
Other Study ID Numbers: CR100712, TMC114HIV4073, DRV-C-10-TW01-001
Study First Received: February 13, 2012
Last Updated: May 27, 2013
Health Authority: Taiwan: Center for Drug Evaluation

Keywords provided by Janssen-Cilag Ltd.:
HIV-1
TMC114
Darunavir
PREZISTA
Ritonavir
Antiretrovirals
Early access
Early treatment
Treatment naive

Additional relevant MeSH terms:
Ritonavir
Darunavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014