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. - This trial will be referred to as ARTEMIS.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 660

Inclusion Criteria

1.Male or female aged 18 years or older. 2.Subjects with documented HIV-1 infection. 3.Screening plasma HIV-1 RNA ³ 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 ICF. 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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. 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)). 4.Treatment for primary HIV infection. 5.Use of any investigational agents within 90 days prior to screening. 6.Use of disallowed concomitant therapy (see Section 5.6.12). 7.Life expectancy of less than 6 months. 8.Pregnant or breast-feeding. 9.Female subject of childbearing potential without use of effective non-hormonal birth control methods or not willing to continue practicing these birth control methods for at least 30 days after the end of the treatment period. 10.Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency). 11.Any active clinically significant disease (e.g., cardiac dysfunction, pancreatitis, acute viral infection) or findings during screening of medical history or physical examination that are expected to compromise the subject's safety or outcome in the trial. 12.Subjects with a grade 3 or 4 laboratory abnormality as defined by DAIDS grading scheme (see Addendum 3: DAIDS AE Grading Table), with the following exceptions unless clinical assessment foresees an immediate health risk to the subject: ·Subjects with pre-existing diabetes or with asymptomatic glucose grade 3 or 4 elevations. ·Subjects with asymptomatic triglyceride or cholesterol elevations of grade 3 or 4. 13.Subjects with calculated creatinine clearance (CLCr) < 70 mL/min. 14.Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC114) or to RTV, LPV, TDF or FTC. 15.Participation in other investigational or cohort trials without prior approval of the sponsor

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method