NCT00115050

CompletedPhase 3

TMC114-C209: A Study of Safety of TMC114 With Low Dose Riton...

Tibotec Pharmaceuticals, Ireland Source

Tibotec Pharmaceuticals, Ireland

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CR002755

Study Type

interventional

Actual enrollment (reported)

260

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2007

Actual (reported)

Study Completion

June 2007

Actual (reported)

Brief Summary

This is an open-label safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral (ARV) therapy and who are ineligible for participation in any other Tibotec-sponsored trial.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 260 participants
Study completion date: June 2007
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 20, 2005
Actual (reported)
First Posted
June 21, 2005
Actual (reported)
Primary Completion
June 2007
Actual (reported)
Study Completion
June 2007
Actual (reported)

Last Updated: June 10, 2011
Status Verified: June 2011
Last Update Submitted: June 2, 2011

Conditions

HIV Infections

Keywords

HIV infectionsAntiretroviralTMC114RitonavirSafety, TMC114-C209

Outcome Measures

Primary Outcomes (1)

The primary objective is to provide early access to TMC114 for highly ARV-experienced HIV-1 infected patients who have failed and exhausted treatment options based on commercially available ARVs

Secondary Outcomes (1)

The secondary objective is to gather additional information on the safety and tolerability of TMC114 in combination with low dose RTV and other ARVs.

Interventions

TMC114Drug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient has voluntarily signed the informed consent before initiation of study procedures
Patient with documented HIV-1 infection

Sponsors & Collaborators

Tibotec Pharmaceuticals, Ireland
Industrylead

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 Syndromes

Study Officials

Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
STUDY DIRECTOR

Enrollment

260 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

June 20, 2005

First Posted

June 21, 2005

Study Start

June 2005

Date type not reported

This date has not been verified as actual or estimated.

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Phase 3Completed

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When to Start Anti-HIV Drugs in Children Infected With HIV (The PREDICT Study)

Phase 3Completed

Patient has limited or no treatment options because of multiple treatment failures

Negative pregnancy test for females of childbearing potential

CD4 cell count \< or = 100 cells/mm³

Viral load \> or = 10,000 copies/mL.

You may not qualify if:

Primary HIV infection, patient is eligible for other Tibotec-sponsored trials
Prior or current participation in a trial with TMC114 (except for Phase I studies conducted in HIV-infected patients)
Use of disallowed concomitant therapy
Use of investigational medication during the trial or within the last 90 days
Female patients who are pregnant or breast feeding or of child bearing potential without the use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial-related activity
Patients with previously demonstrated clinically significant allergy or hypersensitivity to any or the excipients of the investigational medication (TMC114)
Patients with the laboratory abnormalities as defined by a standardized grading scheme based on the Division of AIDS (DAIDS) table (updated version from December 2004) Any grade 3 or 4 toxicity with the following exceptions: Patients with pre-existing diabetes or asymptomatic glucose elevations of grade 3 or 4
Patients with asymptomatic triglyceride elevations of grade 3 or 4, patients with clinical or laboratory evidence of active liver disease, liver impairment/dysfunction or cirrhosis irrespective or liver enzyme levels
Note: Patients co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable. Patients diagnosed with acute viral hepatitis at screening will not be allowed to enroll.

Contact the study team to confirm eligibility.

Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Primary Completion

June 2007

Actual (reported)

Study Completion

June 2007

Actual (reported)

Last Updated

June 10, 2011

Record last verified: 2011-06

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00115050
Data provider: ClinicalTrials.gov
Source updated: 2011-06-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:39 UTC

TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record