NCT01702090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
Last Updated

May 23, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

February 13, 2012

Last Update Submit

May 20, 2016

Conditions

HIV-1

Keywords

HIV-1TMC114DarunavirPREZISTARitonavirAntiretroviralsEarly accessEarly treatmentTreatment naive

Outcome Measures

Primary Outcomes (2)

  • Change in plasma HIV-1 RNA level

    End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.

    Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months

  • Change in plasma CD4 cell count

    End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients.

    Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months

Secondary Outcomes (1)

  • Number of participants affected by an adverse event

    Up to end-of-study visit, an expected average of approximately 3 months

Study Arms (1)

TMC114/ritonavir

EXPERIMENTAL
Drug: TMC114/ritonavir

Interventions

TMC114/ritonavirDRUG

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.

Also known as: PI
TMC114/ritonavir

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Taipei, Taiwan

Location

Related Links

MeSH Terms

Interventions

DarunavirRitonavir

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesAzoles

Study Officials

  • Chien-Ching Hung, MD and PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

October 5, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 23, 2016

Record last verified: 2016-05

Locations

TW(1)