A multicenter,double blind study, Randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk 0518 in combination with an optimized background therapy (OBT), versus optimized background therapy alone, in HIV-Infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies - MK 518 Prot 018

• Conditions: Treatment for patients with HIV; MedDRA version: 14.1Level: PTClassification code 10000807Term: Acute HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2005-005127-34-IT
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-31
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

a. Patient is a male or female at least 16 years of age. b. Patient has screening plasma HIV RNA (determined by the central laboratory) >1000 copies/mL within 60 days prior to the treatment phase of this study. c. Patient is ART experienced and on stable ART for ≥2 months. d. Patient has HIV with documented reduced susceptibility to at least one drug in each of the 3 classes of licensed oral ARTs (NNRTI + NRTI + PI) as per genotypic/phenotypic resistance report from the central laboratory used for this protocol. In cases where the central laboratory resistance sample fails or results are not consistent with prior resistance history, patients may be allowed to enroll based on prior resistance results and ART regimen history, after discussion with the Merck Medical Monitor. e. Patient has the following laboratory values within 35 days prior to the treatment phase of this study: Note: if due to delays in resistance testing or availability of ART in OBT (e.g., enfuvirtide), the 35 day window will expire prior to availability of the resistance results, the patient should have the screening chemistry tests below repeated prior to randomization. 1) Serum creatinine ≤2.0 x upper limit of normal. Subjects with abnormal urinalysis are allowed to enroll if, in the investigators' judgment, the abnormality is clinically insignificant and does not represent evidence of a significant underlying renal disease. 2) Total serum bilirubin ≤2.0 x upper limit of normal; isolated hyperbilirubinemia >2.0 x ULN will be allowed (provided the patient meets criteria 3) and 4) below) if the investigator judges the hyperbilirubinemia is secondary to antiretroviral medications. 3) Alkaline phosphatase ≤5.0 x upper limit of normal. 4) AST (SGOT) and ALT (SGPT) ≤5.0 x upper limit of normal. Note: patients with chronic Hepatitis B and/or C coinfection may be enrolled provided the patients are stable and meet all eligibility criteria. Note: a single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results. f. Patient has a chest x-ray without signs of an active pulmonary disease within 60 days prior to treatment in this study. g. Patient who is of reproductive potential agrees to use an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence. OR Patient who is not of reproductive potentia1 ; is not sexually active, whose current partner(s) is not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception.
Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Does not meet the inclusion criteria for the protocol. b. Female patient is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient is planning to impregnate or provide sperm donation during the study. c. Patient has used any investigational agents within one month prior to treatment in this study with the exception of direct ART agents which are available through expanded access as described in Section I.E.1. Summary of Study Design. d. Patient has used another experimental HIV-integrase inhibitor. e. Patient has used immunosuppressive therapy within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed. f. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol. g. Patient has a current (active) diagnosis of acute hepatitis due to any cause or chronic hepatitis other than stable chronic Hepatitis B and/or C. h. Patient has a history of alcohol or other substance abuse which in the opinion of the investigator would interfere with patient compliance or safety. i. Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient. j. Inability to obtain signed informed consent from a patient age 18 or older, or when a parent/legal representative has provided consent, the inability to obtain assent from a patient 16 or 17 years of age.

Study & Design

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