None listed
Conditions
Interventions
Group 1 Type of group
Raltegravir de 400 mg PO b.i.d. + placebo correspondiente a raltegravir PC q.d. + TRUVADA q.d..
Group name:Group 2 Type of group
Raltegravir de 800 mg PO q.d. + placebo correspondiente a raltegravir PO b.i.d. +TRUVADA q.d.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • The patient is a man or woman at least 18 years of age on the day of signing the informed consent. • The patient is HIV positive as determined by a positive result obtained in an enzyme-linked immunosorbent analysis (ELISA) and has a plasma HIV RNA in the selection (determined by the central laboratory)> 5000 copies / mL within 45 days prior to the treatment phase of this study, and it is recommended for treatment according to the doctor´s evaluation. Local paulas for treatment should be considered when deciding to start therapy. • The patient has not undergone antiretroviral therapy or is defined as having received 30 mL / min, according to the Cockcroft-Gault equation, • 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 maintain abstinence or use (or have his partner use) two acceptable methods of birth control throughout the study. It is defined as acceptable methods of birth control: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condoms, vasectomy.
Exclusion criteria
Exclusion criteria: • The patient has a current history or evidence of any 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 the most convenient thing is not that the patient participant. • At the time of signing the informed consent, the patient is a consumer of recreational or illegal drugs, or has had a recent history (within the last year) of drug or alcohol abuse, or dependence on such substances. • The patient has been treated for a viral infection other than 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 and / or emtricitabine. • The patient is currently participating or has participated in a study with a compound or device under investigation within 45 days of signing the informed consent. • The patient has used another experimental inhibitor of HIV integrase. • The patient has used systemic immunosuppressive therapy within the month prior to treatment in this study. Short cycles of corticosteroids will be allowed (for example, in cases of asthma exacerbation). • The patient requires hemodialysis. • The patient has significant hypersensitivity or other 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, may enter the study as long as they have stable liver function tests, do not show significant impairment of hepatic synthetic function (defined as significant impairment of function Synthetic liver a serum albumin level 1.7 in the absence of another explanation for the abnormal laboratory value) and meet all other inclusion criteria. • The patient is pregnant or breastfeeding, or hopes to conceive (within the duration of the study). The patient hopes to donate eggs (within the duration of the study). The patient expects to donate sperm (within the duration of the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:In Week 48, using the Ultrasensitive trial (version 1.5); If the level is above the LoQ of 50 copies / mL, a confirmatory HIV RNA will be performed within approximately 1 week to confirm viral failure / relapse. Measure:Proportion of patients achieving HIV RNA <50 copies/mL at Week 48. Timepoints:Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:For calculations of change from baseline, baseline measurements are defined as the Randomization / Day 1 value for each patient. In the unusual case that the information for this visit is missing, the value obtained in the most recent selection visit will be used as baseline. Measure:Change from Baseline in CD4 Cell Count Timepoints:The change from baseline in the CD4 cell count will be calculated at each evaluation point with primary interest in Week 48 and Week 96. ; Outcome name:For patients who achieve HIV RNA <50 copies / mL, the time to virological response is the time between randomization and the first of two consecutive values (at least 1 week apart) <50 copies / mL; For patients who do not achieve HIV RNA values <50 copies / mL, the time until the virological response is censored at the time of analysis. Measure:Time to Virological Response (TVR) Timepoints:Week 48 y la Week 96. ; Outcome name:For patients who achieve HIV RNA <50 copies / mL, the time to loss of the virological response is the time between randomization and the first of two consecutive values (at least 1 week apart) above the limit of the 50 copy / mL assay after reaching an HIV RNA <50 copies / mL; For patients who do not achieve HIV RNA values <50 copies / mL, the time to loss of the virological response is 0 weeks. Measure:Time to Loss of Virological Response (TLOVR) Timepoints:Week 48 and Week 96. | — |
Countries
Denmark, France, Germany, Italy, Netherlands, Peru, Portugal, Spain, United Kindgdom
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed