Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 13, 2012
May 27, 2013
February 2012
June 2012   (final data collection date for primary outcome measure)
  • 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.
Change in plasma HIV-1 RNA and change in 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.
Complete list of historical versions of study NCT01702090 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Early Access to TMC114/r and Other AVT for Treatment-naive or Early Treatment Experienced in HIV-1 Patients
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

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1
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
Experimental: TMC114/ritonavir
Intervention: Drug: TMC114/ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01702090
CR100712, TMC114HIV4073, DRV-C-10-TW01-001
Yes
Janssen-Cilag Ltd.
Janssen-Cilag Ltd.
Not Provided
Principal Investigator: Chien-Ching Hung, MD and PhD National Taiwan University Hospital
Janssen-Cilag Ltd.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP