TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose Response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.
2 other identifiers
interventional
330
2 countries
39
Brief Summary
The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Oct 2003
Typical duration for phase_2 hiv-infections
39 active sites
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
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 10, 2003
CompletedFirst Posted
Study publicly available on registry
October 15, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedSeptember 20, 2016
September 1, 2016
1.3 years
October 10, 2003
September 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the dose-response relationship of antiviral activity of the TMC114/RTV dose regimens at 24 Wks in order to determine the optimal dose.
24 weeks
Secondary Outcomes (1)
To evaluate safety and tolerability over 24 to 144Wks; The durability of the antiviral activity; The effect of functional monotherapy with TMC114 over 2 weeks in different doses; and The dose-response by comparing the different TMC114/RTV dosages.
144 weeks
Study Arms (5)
001
EXPERIMENTALTMC114/rtv 400mg TMC114/100mg rtv once daily
005
NO INTERVENTIONControl Group Control Group, no intervention
004
EXPERIMENTALTMC114/rtv 600mg TMC114/100mg rtv twice daily
003
EXPERIMENTALTMC114/rtv 400mg TMC114/100mg rtv both twice daily
002
EXPERIMENTALTMC114/rtv 800mg TMC114/100mg rtv once daily
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, age 18 years or older
- Documented HIV-1 infection
- Stable PI regimen for at least 8 weeks prior to screening
- Plasma viral load at screening above 1000 HIV-1 RNA copies/ml
- Prior use of more than 1 NRTI for at least 3 months
- Prior use of one or more NNRTIs as part of a failing regimen
- At least 1 primary PI mutation as defined by the IAS guidelines
- Treatment with at least 1 PI for a total of at least 3 months
- Patient has given informed consent
You may not qualify if:
- Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection
- Current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures
- NNRTI as part of therapy at screening
- Patients on a treatment interruption at screening
- Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening
- Hepatitis A, B, or C.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Oakland, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
West Hollywood, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Altamonte Springs, Florida, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Miami Beach, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Vero Beach, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Camden, New Jersey, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Huntersville, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Columbia, South Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Galveston, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Hampton, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Buenos Aires, Argentina
Related Publications (2)
Clotet B, Bellos N, Molina JM, Cooper D, Goffard JC, Lazzarin A, Wohrmann A, Katlama C, Wilkin T, Haubrich R, Cohen C, Farthing C, Jayaweera D, Markowitz M, Ruane P, Spinosa-Guzman S, Lefebvre E; POWER 1 and 2 study groups. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. Lancet. 2007 Apr 7;369(9568):1169-78. doi: 10.1016/S0140-6736(07)60497-8.
PMID: 17416261RESULTDe Meyer SM, Spinosa-Guzman S, Vangeneugden TJ, de Bethune MP, Miralles GD. Efficacy of once-daily darunavir/ritonavir 800/100 mg in HIV-infected, treatment-experienced patients with no baseline resistance-associated mutations to darunavir. J Acquir Immune Defic Syndr. 2008 Oct 1;49(2):179-82. doi: 10.1097/QAI.0b013e318183a959.
PMID: 18769351DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tibotec Pharmaceuticals Clinical Trial
Tibotec Pharmaceutical Limited
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2003
First Posted
October 15, 2003
Study Start
October 1, 2003
Primary Completion
February 1, 2005
Study Completion
November 1, 2007
Last Updated
September 20, 2016
Record last verified: 2016-09