NCT02187107

Brief Summary

The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants. In addition, antiviral activity and immunological effect were also evaluated.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 hiv

Timeline
Completed

Started Jan 2005

Typical duration for phase_2 hiv

Geographic Reach
7 countries

10 active sites

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

January 1, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

8 months

First QC Date

February 25, 2014

Last Update Submit

August 22, 2014

Conditions

HIV

Keywords

HIVAIDSTMC114RitonavirNorvirDarunavir

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability of TMC114/RTV 600/100 mg combination

    Baseline, up to the end of follow-up period (approximatelly 100 weeks)

Secondary Outcomes (2)

  • Number of patients with HIV-1 plasma viral load level <50 copies/mL (TLOVR, non-VF censored)

    Week 48, Week 96

  • Change in CD4 cells absolute count

    Week 48, Week 96

Study Arms (1)

TMC114 + rtv

EXPERIMENTAL

Every participant recieves 2 tablets of TMC114, 300 mg, combined with one tablet of rtv (ritonavir), 100mg, orally twice daily, every 12 hours

Drug: TMC114Drug: rtv

Interventions

TMC114DRUG

300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® Orange

TMC114 + rtv
rtvDRUG

100 mg tablet of Norvir®

Also known as: Norvir
TMC114 + rtv

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be diagnosed with HIV
  • Previously randomized in trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials
  • Agreed to take at least 2 antiretroviral agents from baseline onwards
  • Could comply with the protocol requirements
  • General medical condition, in the investigator's opinion, was not interfering with the assessments and the conduct of the trial

You may not qualify if:

  • A disallowed concomitant therapy
  • Current or past history of active alcohol and/or drug use
  • Pregnant or breast-feeding females
  • Any active or unstable medical condition (e.g., tuberculosis; cardiac dysfunction; pancreatitis; acute viral infections)
  • Clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis
  • Clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication
  • Laboratory abnormalities at screening (criteria variable according to the test)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Darlinghurst, Australia

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Copenhagen, Denmark

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Szczecin, Poland

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

DarunavirRitonavir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tibotec Pharmaceuticals Limited, Ireland Clinical Trial

    Tibotec Pharmaceuticals, Ireland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

July 10, 2014

Study Start

January 1, 2005

Primary Completion

September 1, 2005

Study Completion

March 1, 2009

Last Updated

August 25, 2014

Record last verified: 2014-08

Locations

DK(1)RU(1)AU(1)DE(4)GB(1)BE(1)PL(1)