A MULTICENTER, DOUBLE BLIND, RANDOMIZED, CONTROLLED STUDY WITH ACTIVE COMPARATOR TO EVALUATE THE SECURITY AND ANTIRETROVIRAL ACTIVITY OF MK-0518 COMPARED WITH EFAVIRENZ IN PATIENTS INFECTED WITH HIV NOT SUBJECT TO TREATMENT, EACH IN COMBINATION WITH TRUVADA ™ - EXTENSION STUDY
- Conditions
- -B20 Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases-B24 Unspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesUnspecified human immunodeficiency virus [HIV] diseaseB20B24
- Registration Number
- PER-066-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 43
• The patient is a man or woman of at least 18 years of age on the day of signing the informed consent.
• The patient is positive YIH as determined by a positive result obtained in an enzyme-linked immunosorbent assay (ELISA) and has a YIH RNA in plasma in the selection (determined by the core laboratory)> 5000 copies / mL within the 60 days prior to the treatment phase of this study, and it is recommended for treatment according to the doctor´s evaluation. Local guidelines for treatment should be considered when deciding when to start therapy.
• The patient has not undergone an ART.
• The patient has the following laboratory values within 35 days prior to the treatment phase of this study: serum creatinine <2.0 x normal upper limit, alkaline phosphatase <5.0 x normal upper limit, AST (SGOT) and ALT (SGPT) ) <5.0 x normal upper limit
• At the time of selection the patient has a calculated creatinine clearance> 30 mL / min, according to the Cockcroft-Gault equation, which is as follows (and 0.85X this value for women)
• In the opinion of the researcher, the patient should be considered clinically stable and have no signs or symptoms of active infection at the time of entering the study; that is, the clinical picture and all chronic drugs should not change for at least 2 weeks before the start of treatment in this study.
• The patient is potentially fertile and agrees to use an acceptable method of birth control throughout the study. Intrauterine device (IUD), diaphragm with spermicide, condoms or abstinence are defined as acceptable method of birth control.
• The patient has a history or current indications of a condition, therapy, laboratory abnormality or other circumstance that could confuse the results of the study, or interfere with their participation throughout the study, so that it is not convenient for the patient participant.
• At the time of signing the informed consent the patient is a consumer of recreational or illicit drugs, or has had a recent history (within the last year) of drug or alcohol abuse, or dependence on such substances.
• The patient has received treatment for a viral infection different from HIV, such as hepatitis B, with an agent that is active against HIV, including, without limitation, adefovir, tenofovir, emtricitabine or lamivudine.
• The patient has documented resistance to tenofovir, emtricitabine and / or efavirenz.
• The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days of signing the informed consent.
• The patient has used another experimental inhibitor of HIV integrase.
• The patient has used a systemic immunosuppressive therapy within the month before treatment in this study. Short courses of corticosteroids will be allowed (for example, in cases of asthma exacerbation).
• The patient requires hemodialysis.
• The patient has significant hypersensitivity or another contraindication to any of the components of the study drugs.
• The patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and / or C, can enter the study as long as they have stable liver function tests and meet all inclusion criteria. Patients who, in the opinion of the investigator, show evidence of inadequate hepatic synthetic function, such as hypoalbuminemia or prolonged PT and PTT, should be excluded.
• The patient is pregnant or breastfeeding, or expects to conceive (within the duration of the study). The patient hopes to donate an ovum (within the duration of the study). The patient expects to donate sperm (within the duration of the study).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method