A randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114/ritonavir versus lopinavir/ritonavir in treatment-naïve HIV-1 infected subjects. - This trial will be referred to as ARTEMIS.

Tibotec Pharmaceuticals Limited0 sites660 target enrollmentOctober 31, 2005

Overview

No summary available.

Registry

who.int

Start Date

October 31, 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Tibotec Pharmaceuticals Limited

•Note: Re\-testing of screening values that lead to exclusion will be allowed only once using an unscheduled visit.
•Subjects who meet all of the following criteria are eligible for this trial.
•1\. Male or female aged 18 years or older.
•2\. Subjects with documented HIV\-1 infection.
•3\. Screening plasma HIV\-1 RNA \= 5000 copies/mL.
•4\. Subjects qualify for treatment initiation based on the investigator's assessments and/or according to treatment guidelines.
•Note: Most current treatment guidelines recommend considering initiation of ART when CD4 cell counts are below 350 cells/µL. However, clinical situations may warrant initiating ART with CD4 cell counts above 350 cells/µL. Examples of such situations would include rapidly declining CD4 cell counts over time, high plasma viral load, history of AIDS\-defining illnesses or severe symptoms of HIV infection.
•5\. Subjects have voluntarily signed the informed consent form.
•6\. Subjects can comply with the protocol requirements.
•7\. General medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.

•Note: Re\-testing of screening values that lead to exclusion will be allowed only once using an unscheduled visit.
•Subjects meeting one or more of the following criteria cannot be selected.
•1\. Presence of any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993\) with the following exceptions:
•\- Stable cutaneous Kaposi’s Sarcoma (i.e., no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial time period.
•\- Wasting syndrome.
•\[Note: An AIDS defining illness...]
•\[Note: Primary and secondary prophylaxis...]
•2\. Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject's safety or adherence to the trial protocol.
•3\. Previous or current use of ARVs (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, lamivudine, emtricitabine)).
•Note: Women who used a single dose of 200 mg of nevirapine to prevent mother\-to\-child transmission (MTCT) are allowed in the trial, as long as they have never received other ARVs. Women who used zidovudine to prevent MTCT will not be allowed as this may result in reduced susceptibility to the fixed background regimen.