NCT00513513

TerminatedPhase 2

TMC114-C227: A Study to Evaluate the Effectiveness and Safet...

Tibotec Pharmaceuticals, Ireland Source

Tibotec Pharmaceuticals, Ireland

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CR010612

Study Type

interventional

Actual enrollment (reported)

7

Locations

0 countries

Sites

N/A

Timeline

Study Start

September 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2007

Actual (reported)

Study Completion

October 2007

Actual (reported)

Brief Summary

This is an open label study (no placebos are used; all patients will receive the true medication) to evaluate the effectiveness of TMC114/rtv in treatment naÃ-ve (never previously received anti-HIV drugs), HIV 1 infected patients.

Registry Overview

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

Recruitment status: terminated
Actual enrollment (reported): 7 participants
Study completion date: October 2007
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

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

Study Start
September 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 6, 2007
Actual (reported)
First Posted
August 8, 2007
Actual (reported)
Primary Completion
September 2007
Actual (reported)
Study Completion
October 2007
Actual (reported)

Last Updated: April 26, 2010
Status Verified: April 2010
Last Update Submitted: April 22, 2010

Conditions

HIV Infections

Keywords

HIVAIDSTMC114Protease inhibitorDarunavirAntiretroviral agentsTreatment Naive

Outcome Measures

Primary Outcomes (1)

The primary objective is to evaluate sustained anti-viral activity of TMC114/rtv monotherapy in treatment naive, HIV 1 subjects defined by decrease of >1 log viral load (VL) at week 4, VL <400 copies/ml at week 8 and VL< 50 copies/ml at weeks 24 and 48.

Secondary Outcomes (1)

The secondary objectives are to evaluate safety and tolerability of TMC114/rtv over 48 weeks, to evaluate immunologic response, to evaluate the possible development of resistance and to monitor potential changes in body shape.

Interventions

TMC114 (darunavir) / ritonavirDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients with documented HIV-1 infection
For the first 11 subjects (Panel A), screening plasma HIV-1 viral load is =10000 copies/mL and \<100000 copies/mL

Sponsors & Collaborators

Tibotec Pharmaceuticals, Ireland
Industrylead

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

DarunavirRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital Diseases

Study Officials

Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
STUDY DIRECTOR

Enrollment

7 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 8, 2007

Study Start

September 2006

Date type not reported

This date has not been verified as actual or estimated.

Completed

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TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use

Phase 2Completed

NCT00397566

A Multiple Ascending Dose Study of BMS-707035 in HIV-1 Infected Subjects

Phase 2Withdrawn

NCT00081978

TMC125-C223: TMC125 in HIV-1 Infected Subjects

Phase 2Completed

NCT00006339

Safety and Effectiveness of an Anti-HIV Drug Combination With and Without Hydroxyurea in Patients With Early HIV Infection

Phase 2Withdrawn

NCT00021762

Effects of Immunization With HIV-1 Immunogen Plus Anti-HIV Treatment Interruption on the Levels of HIV

Phase 2Withdrawn

NCT00350623

Investigation of V520 in a HIV Vaccine Dose Refinement Study (V520-027)(TERMINATED)

Phase 2Terminated

For the second set of 13 patients (Panel B), plasma HIV-1 viral load is =20000 copies/mL and \<500000 copies/mL

Patients with CD4+ cell count above 100 cells/µl

Patients have voluntarily signed the ICF

Patients can comply with the protocol requirements

Patient's general medical condition, in the investigator's opinion, does not interfere with the assessments and the completion of the trial.

You may not qualify if:

Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with some exceptions
Previous or current use of antiretroviral (ARVs/anti-HIV drugs) (including both investigational as well as commercially available ARVs indicated for the treatment of HIV-infection and ARVs for treatment of hepatitis B infection with anti-HIV activity (e.g., adefovir)
Having one of protocol listed 1 PI, NRTI, or NNRTI resistance associated mutation at screening
Patients with primary HIV infection
Female patients of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period
Any active clinically significant disease (e.g., abnormal heart function, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the patient's safety or outcome in the trial.

Contact the study team to confirm eligibility.

Urogenital Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Slow Virus Diseases

Intervention Hierarchy (Ancestors)

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

Primary Completion

September 2007

Actual (reported)

Study Completion

October 2007

Actual (reported)

Last Updated

April 26, 2010

Record last verified: 2010-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00513513
Data provider: ClinicalTrials.gov
Source updated: 2010-04-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:28 UTC

Study Stopped

TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously

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

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

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