TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
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ClinicalTrials.gov Identifier: NCT00071097 |
Recruitment Status
:
Completed
First Posted
: October 15, 2003
Last Update Posted
: September 20, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: TMC114/rtv | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | February 2005 |
Actual Study Completion Date : | November 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
TMC114/rtv 400mg TMC114/100mg rtv once daily
|
Drug: TMC114/rtv
400mg TMC114/100mg rtv once daily
|
No Intervention: 005
Control Group Control Group, no intervention
|
|
Experimental: 004
TMC114/rtv 600mg TMC114/100mg rtv twice daily
|
Drug: TMC114/rtv
600mg TMC114/100mg rtv twice daily
|
Experimental: 003
TMC114/rtv 400mg TMC114/100mg rtv both twice daily
|
Drug: TMC114/rtv
400mg TMC114/100mg rtv both twice daily
|
Experimental: 002
TMC114/rtv 800mg TMC114/100mg rtv once daily
|
Drug: TMC114/rtv
800mg TMC114/100mg rtv once daily
|
- 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. [ Time Frame: 24 weeks ]
- 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. [ Time Frame: 144 weeks ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00071097

Study Director: | Tibotec Pharmaceuticals Clinical Trial | Tibotec Pharmaceutical Limited |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tibotec Pharmaceuticals, Ireland |
ClinicalTrials.gov Identifier: | NCT00071097 History of Changes |
Obsolete Identifiers: | NCT00980928 |
Other Study ID Numbers: |
CR006778 TMC114-C202 |
First Posted: | October 15, 2003 Key Record Dates |
Last Update Posted: | September 20, 2016 |
Last Verified: | September 2016 |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
HIV TMC114 Ritonavir |
Tolerability Safety and efficacy TMC114-C211 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Darunavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |