A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen versus Lopinavir/Ritonavir in Combination with Lamivudine/Zidovudine in Antiretroviral Naive Patients - MONARK

• Conditions: HIV-1 Infection; MedDRA version: 7.0Level: LLTClassification code 10020192

• Registration Number: EUCTR2004-000816-24-ES
• Lead Sponsor: Abbott France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-13
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/ Independent Ethic Committee (IEC)+, after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
2.Subject is at least 18 years of age.
3.If female, subject is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one barrier method of birth control.
4.If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative.
5.Subject is not breast-feeding.
6.Subject is naïve to antiretroviral treatment with reverse transcriptase inhibitor or protease inhibitor.
7.Subject has a plasma HIV RNA level < 100 000 copies/mL at screening.
8.Subject has a CD4 cell count > 100 cells/mm3 at screening.
9.Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
10.Subject has a Karnofsky Score greater than or equal to 70.
11.Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would adversely affect his/her participating in this study.
12.Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and metheylergonovine), rifampin, lovastatin, simvastatin, and St. John’s wort.
13.Subject agrees not to take any medication during the study, including over the counter medicine, herbal medications, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
14.Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Abbott.

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

1.Subject with an HIV primo-infection status.
2.Presence of the following mutation:
In the protease: one among 32, 47, 48, 50, 82, 84, 90 OR more than 3 mutations from the LPV mutation score 10, 20, 24, 46, 53, 54, 63, 71
In the reverse transcriptase: 215 or 184.
3.Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse.
4.Subject has a history of psychiatric illness.
5.Screening laboratory analyses show any of the following abnormal laboratory results:Hemoglobin = 8.0 g/dL,
Absolute neutrophil count = 750 cells/µL,
Platelet count = 50,000 per mL,
ALT or AST = 3.0 x Upper Limit of Normal (ULN),
Creatinine = 1.5 x Upper Limit of Normal (ULN),
6.Subject has received any investigational drug within 30 days prior to study drug administration.
7.For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.

Study & Design

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