Completed

An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.

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What is being tested

TMC114

Drug
Who is being recruted

HIV Infection

Over 18 Years
+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2003

See protocol details

Summary

Principal SponsorTibotec Pharmaceuticals, Ireland
Last updated: June 20, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2003Actual date on which the first participant was enrolled.

The primary objective of the TMC114-C215 study is to evaluate the safety and tolerability of TMC114/RTV over time. The secondary objectives are to evaluate the antiviral activity over time and to evaluate the immunological effect over time. The study will continue for 144 weeks after study medication has begun. For patients failing treatment, they must have participated in the TMC114-C213 or TMC114-C202 for at least 12 weeks and meet specific virologic failure criteria. It is estimated that approximately 150 patients may meet these criteria. Major inclusion and exclusion criteria are listed below. For new patients, they must have been on prior antiretroviral therapy, including more than one nucleoside reverse transcriptase inhibitor (NRTI), one non-nucleoside reverse transcriptase inhibitor (NNRTI) and a protease inhibitor (PI). At least one primary PI mutation must be present at screening. Many of the same centers that are participating in the TMC114-C213 and TMC-114 -C202 studies are also participating in the TMC114-C215 study. All sites have the chance to recruit rollover patients into the TMC114-C215 study and some sites listed had approval to recruit new patients into the study. The recruitment of new patients for the TMC114-C215 trial has been fully enrolled. The TMC114-C202 and TMC114-C213 have completed so no more patients are enrolled in this study. Two 300mg/100mg Darunavir/Ritonavir tablets twice daily for 144 weeks.

Official TitleAn Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects. 
Principal SponsorTibotec Pharmaceuticals, Ireland
Last updated: June 20, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
555 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infection
Criteria
5 inclusion criteria required to participate
Previous participation in the TMC114-C202 or TMC114-C213 trials
Significant virologic failure during participation in the above trials
Study participation in the treatment phase of the original trial for a total of at least 12 weeks before TMC114-C215 screening
Patient agrees to take TMC114/RTV with at least 2 other antiretrovirals (NRTIs), with or without T-20, from baseline onwards

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5 exclusion criteria prevent from participating
Use of disallowed concomitant therapy
Patient with clinical or laboratory evidence of active liver disease, liver impairment/ dysfunction or cirrhosis irrespective of liver enzyme levels
Any active or unstable medical condition that, in the investigator's opinion, would compromise the subject's safety
Patient with laboratory abnormalities at screening as defined by ACTG grading scheme as listed in the protocol

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
TMC114600/100 mg tablets of TMC114/rtv BID for 144 weeks or until commercial available
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 68 locations
Suspended
Unknown FacilityBirmingham, United StatesSee the location
Suspended
Unknown FacilityBeverly Hills, United States
Suspended
Unknown FacilityLa Jolla, United States
Suspended
Unknown FacilityLong Beach, United States
Completed68 Study Centers