NCT00964327

Brief Summary

The purpose of this study is to determine the antiviral activity, safety and tolerability of 14 days of different doses of TMC114 to treat HIV-1 positive patients whose condition is failing on a current treatment regimen that includes a protease inhibitor (PI) (a medication used to reduce the amount of HIV virus in the blood).To be considered for the study, patients must have a documented resistance to at least 2 of the current PIs. Pharmacokinetics and pharmacodynamics of TMC114 will also be assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Aug 2001

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

August 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

Enrollment Period

2.2 years

First QC Date

July 27, 2009

Last Update Submit

May 18, 2011

Conditions

HIV Infections

Keywords

TMC114-C201TMC114HIVdarunavir

Outcome Measures

Primary Outcomes (1)

  • To determine the antiviral activity of TMC114.

    Screening, days -7, -3, 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 , 15, follow-up weeks 1, 3 and 6

Secondary Outcomes (3)

  • nadir of viral load

    Screening, days -7, -3, 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 , 15, follow-up weeks 1, 3 and 6

  • Pharmacokinetics (PK) / Pharmacodynamics (PD): Plasma concentration of TMC114 and efficacy and safety data will be analyzed to find relationships between PK and PD.

    12 visits

  • CD4 count

    7 visits

Interventions

TMC114DRUG

Eligibility Criteria

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

You may qualify if:

  • Patient has a documented HIV-1 infection with a viral load at screening visit above 2,000 HIV copies/ml
  • Currently treated with a failing antiretroviral regimen consisting of NRTIs together with one or more PI(s)
  • Has a resistance against at least 2 of the currently used PIs
  • Patient agrees not to change the current therapy until end of run-in and agrees not to change NRTIs until the end of treatment period
  • No current AIDS defining illnesses

You may not qualify if:

  • NNRTI (non-nucleoside reverse transcriptase inhibitor) containing regimen, two weeks prior to screening
  • Suspicion of alcohol abuse or drug abuse, leading to non-compliance
  • History of significant drug allergy induced by PIs
  • CD4 count \< 50
  • Life expectancy of less than 6 months
  • Pregnant or breast feeding females
  • Females of childbearing potential without use of a highly effective birth control method or not willing to continue practicing this birth control method for at least 14 days after the end of the treatment
  • Received an investigational drug within 30 days prior to the trial drug administration
  • Patients with clinically significant laboratory abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

Darunavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tibotec Pharmaceuticals Limited Clinical Trial

    Tibotec Pharmaceutical Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2009

First Posted

August 24, 2009

Study Start

August 1, 2001

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

May 19, 2011

Record last verified: 2010-04