None listed
Conditions
Interventions
Group 1 Type of group
400 mg of MK-0518 b.i.d. for 144 weeks, then 400 mg of MK-0518 b.i.d. for 240 more weeks. Additionally, tenofovir of 300 mg q.d., plus lamivudine of 300 mg q.d., plus the placebo corresponding to efavirenz.
Group name:Group 5 Type of group
600 mg of Efavirenz q.h.s. for 144 weeks, then 600 mg of Efavirenz q.h.s. for 240 more weeks. Additionally, tenofovir of 300 mg q.d., plus lamivudine of 300 mg q.d., plus the placebo corresponding to efavirenz.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Patients who complete the original study until Week 144 will be able to continue with this second period of study extension (the visit 14 days after therapy is not necessary in the case of patients entering the extension). -All patients must provide informed consent to Participate in the extension.
Exclusion criteria
Exclusion criteria: NA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:They will be presented in tables by treatment group with MK-0518 in a dose of 400 mg b.i.d. and efavirenz: (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. Measure:Proportion of patients presenting types of clinical or laboratory adverse events during the 96-week extension, for a total of 240 weeks Timepoints:240 weeks ; Outcome name:Changes from baseline in plasma HIV RNA (log10 copies / mL, as measured by the AMPLICOR HIV-1 Monitor ™ Test) and CD4 cell count will also be summarized per treatment group at each assessment point up to Week 240 Measure:Proportion of patients who reached plasma HIV RNA levels below the threshold of reliable quantification of the AMPLICOR HIV-1 Monitor Test Timepoints:240 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of RNA levels using the AMPLICOR HIV-1 Monitor Standard assay Measure:Proportion of patients with HIV RNA levels below the quantification threshold for the AMPLICOR HIV-1 Monitor Standard trial (<400 copies / mL, Version 1.5) Timepoints:Week 240 ; Outcome name:Measurement of plasma RNA levels Measure:Change from baseline in HIV RNA in plasma (log10 copies / mL) Timepoints:240 weeks ; Outcome name:Measurement of CD4 cell count Measure:Change with respect to the baseline in the CD4 cell count. Timepoints:240 weeks | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed