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.

• Conditions: HIV-1

• Registration Number: EUCTR2005-002486-36-PT
• Lead Sponsor: Tibotec Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-26
• Last Update Posted: 8 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 not clinically stabilized for at least 30 days will be considered as currently active.
Note: Primary and secondary prophylaxis for an AIDS defining illness is allowed in case the medication used is not part of the disallowed medication.

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 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.
Note: Subjects treated for postexposure prophylaxis will not be allowed.

4. Treatment for primary HIV infection.

5. Use of any non-ARV investigational agents within 90 days prior to screening.

6. Use of disallowed concomitant therapy.

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.
Note: Hormonal based contraception may not be reliable when taking TMC114, therefore to be eligible for this trial women of childbearing potential should either:
(1) use a double barrier method to prevent pregnancy (i.e., use a condom with either diaphragm or cervical cap), or,
(2) use hormonal based contraceptives in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap or female condom), or,
(3) use an intra uterine device (IUD) in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap or female condom), or,
(4) be non-heterosexually active, practice sexual abstinence or have a vasectomized partner (confirmed sterile).
Note: Women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential.

10. Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insuffiency).
Note: Subjects co-infected with chronic hepatitis B or C will be allowed to enter the trial if their condition is clinically stable and is not expected to require treatment during the trial period. Subjects diagnosed with acute viral hepatitis at screening will not be allowed in the trial.
Please refer to the package insert with respect to proper care of hepatitis B co-infection as TDF (300 mg) and FTC (200 mg) are included in the fixed backgro

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified