None listed
Conditions
Interventions
Group MK-0518 Type of group
Those patients who received a dose of MK-0518 in phase II of the study (for 48 weeks) will now receive 400 mg PO q / 24 h of MK-0518 plus tenofovir at a dose of 300 mg q.d. and lamivudine in a dose of 300 mg q.d. for 96 weeks
Group name:Group Efavirenz Type of group
Those patients who have received Efavirenz in phase II of the study (for 48 weeks) will now continue to receive Efavirenz plus tenofovir at a dose of 300 mg q.d. and lamivudine in a dose of 300 mg q.d. for 96 weeks
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: a. The patient is a man or woman 18 years of age or older. b. The patient is HIV positive c. The patient has a CD4 cell count, at the time of selection,> 100 cells / mm3 d. The patient has not been subjected to antiretroviral therapy (ART) e. The patient had normal laboratory values ​​within 21 days prior to the treatment phase of the present study f. The patient has a chest x-ray without signs of active lung disease within 21 days prior to treatment g. The patient does not wish to receive any other antiretroviral therapy for the duration of this study h. The patient, who is potentially reproductive, agrees to use a method of birth control throughout the study.
Exclusion criteria
Exclusion criteria: a. The female patient is pregnant or breastfeeding b. The patient has received approved or experimental antiretroviral agents in the past c. The patient has used immunological therapy agents, immunosuppressive therapy and / or agents under investigation within the month prior to treatment d. The patient has been treated with adefovir or lamivudine for another viral infection. e. The patient needs, or is anticipated to need, chronic daily prescription medications f. The patient needs, or is anticipated to need, some prohibited medication g. Significant hypersensitivity or other contraindication to any of the components of study drugs h. The patient has documented resistance to tenofovir, lamivudine, and / or efavirenz. i. The patient has a history of renal or urinary obstructive disease, or a calculated creatinine clearance, at the time of selection, 1 month) in liver function tests n. The patient has a history of alcohol or other substance abuse or. The patient has some condition, pre-study laboratory abnormality or a history of some disease, which in the opinion of the investigator, could confuse the results of the study or pose an additional risk to the administration of the study drugs to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HIV RNA in plasma with the Test AMPLICOLOR HIV-1 Monitor Version 1.5 Measure:Efficacy of MK-0518: Proportion of patients with HIV RNA levels <400 copies / ml. Timepoints:Weeks 60, 72, 84, 96, 108, 120, 132, 144 (Counting from phase I) ; Outcome name:Clinical evaluation Blood measurements of: Creatinine, INR, hemoglobin, neutrophil count, platelets, total bilirubin, alkaline phosphatase, transaminases. 12-lead EKG. Measure:Proportions of patients presenting the following types of clinical or laboratory adverse events: (1) at least one adverse event; (2) an adverse event related to the drug; (3) a serious adverse event; (4) serious adverse events related to the drug, (5) adverse events that lead to discontinuation. Timepoints:Clinical evaluation: when the event is presented. Blood measurements: Weeks 60, 72, 84, 96, 108, 120, 132, 144 (counting from phase I). EKG: weeks 96 and 144 (counting from phase I). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of HIV RNA in plasma with the Test AMPLICOLOR HIV-1 Monitor Version 1.5 Measure:Proportion of patients with HIV RNA levels <50 copies / ml. Change from baseline in HIV RNA in plasma (log10 copies / ml). Change with respect to the baseline in the CD4 cell count. Timepoints:Test AMPLICOLOR: Weeks 60, 72, 84, 96, 108, 120, 132, 144 (Counting from phase I). CD4 count: Weeks 60, 72, 84, 96, 108, 120, 132, 144 (counting from phase I), in case of viral failure and if a discontinuation occurs. | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed