None listed
Conditions
Interventions
Group 1 Type of group
400 mg of MK-0518, which can be taken PO b.i.d. (orally twice a day) regardless of the food, and the placebo corresponding to efavirenz, which will be taken PO q.h.s. on an empty stomach, preferably at bedtime.
Group name:Group 2 Type of group
600 mg of efavirenz, which will be taken PO q.h.s. (orally at bedtime) on an empty stomach, preferably at bedtime, and the placebo corresponding to MK-0518, which will be taken PO b.i.d. regardless of the food.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 18 Years
Inclusion criteria
Inclusion criteria: • 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 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.
Exclusion criteria
Exclusion criteria: • 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).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The CD4 cell count will be determined at each visit, through laboratory tests. Measure:Variation in CD4 cell counts Timepoints:Week 48 ; Outcome name:The blood samples for the viral resistance tests will be obtained in the Selection with the purpose of determining the resistance to efavirenz, emtricitabine and tenofovir through tests available in the market. Additional strength tests can be carried out with samples of the selection. Measure:Viral resistance Timepoints:Week 48 | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The level of HIV RNA will be measured using the AMPLICOR HIV-1 Monitor Standard (version 1.5) assay for each patient; If the level of HIV RNA is below the LoQ of 400 copies / mL according to the Standard assay, the blood sample will be re-examined using the Ultrasensitive assay (version 1.5). Measure:Proportion of patients attaining plasma HIV RNA <50 copies / mL in Week 48 Timepoints:Week 48 | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed