Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infection

Keywords

Human Immunodeficiency VirusTreatment ExperiencedTMC114-C214

Outcome Measures

Primary Outcomes (1)

Number of Participants with Viral load <400 copies/mL per TLOVR algorithm at Week 48 (Per Protocol Population)
48 weeks

Secondary Outcomes (2)

Number of Participants with Adverse Events
96 weeks
Number of Participants With Viral load <400 copies/mL per TLOVR Algorithm at Week 96 (Per Protocol Population)
96 Weeks

Study Arms (2)

002

EXPERIMENTAL

LPV/rtv One 400mg LPV tablet twice daily with 100mg RTV

Drug: LPV/rtv

001

EXPERIMENTAL

TMC114/rtv Two 300mg TMC114 tablets twice daily with 100mg RTV

Drug: TMC114/rtv

Interventions

LPV/rtvDrug

One 400mg LPV tablet twice daily with 100mg RTV

002

TMC114/rtvDrug

Two 300mg TMC114 tablets twice daily with 100mg RTV

001

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:

Patient has documented HIV-1 infection
Treatment with an Antiretroviral regimen (containing at least 2 NRTIs in combination with at least 1 NNRTI and/or 1 PI) for at least 12 weeks

Sponsors & Collaborators

Tibotec Pharmaceuticals, Ireland
Industrylead

Study Sites (103)

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Beverly Hills, California, United States

Long Beach, California, United States

Los Angeles, California, United States

San Francisco, California, United States

West Hollywood, California, United States

Related Publications (2)

Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Bethune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007 Jul 7;370(9581):49-58. doi: 10.1016/S0140-6736(07)61049-6.
PMID: 17617272RESULT
Banhegyi D, Katlama C, da Cunha CA, Schneider S, Rachlis A, Workman C, De Meyer S, Vandevoorde A, Van De Casteele T, Tomaka F. Week 96 efficacy, virology and safety of darunavir/r versus lopinavir/r in treatment-experienced patients in TITAN. Curr HIV Res. 2012 Mar;10(2):171-81. doi: 10.2174/157016212799937218.
PMID: 22339125DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
STUDY DIRECTOR

Enrollment

604 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 13, 2005

First Posted

May 16, 2005

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

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 (2)

Study Arms (2)

002

001

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (103)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

TMC114-C214: Trial of TMC114 Administered With Low Dose Ritonavir (RTV) in HIV-1 Infected Treatment Experienced Patients

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 (2)

Study Arms (2)

002

001

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (103)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations