None listed
Conditions
Interventions
Group 1 Type of group
MK-0518 400 mg twice daily (b.i.d.) by mouth (p.o.) with optimized background therapy. Treatment period of 48 weeks.
Group name:Group 2 Type of group
Placebo b.i.d. p.o. with optimized background therapy. Treatment period of 48 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Age
16 Years to 90 Years
Inclusion criteria
Inclusion criteria: • The patient is a man or woman at least 16 years old. • The patient has plasma HIV RNA in the selection (determined by the central laboratory)> 1000 copies / mL within 60 days prior to the treatment phase of this study. • The patient has had ART treatment and has had a stable ART treatment for> 2 months before selection. • The patient has HIV with a documented susceptibility reduced to at least one drug from each of the 3 classes of authorized oral ART (NNRTI + NRTI + PI) as determined by a genotypic / phenotypic resistance report from the central laboratory used for present protocol In cases where the central laboratory resistance sample fails or the results are not consistent with the previous resistance history, patients may be allowed to enroll based on their previous resistance results and the ART regimen history, after discuss it with the Merck Medical Monitor. • The patient has had laboratory values ​​outside the normal ranges within 35 days prior to the treatment phase of this study. • The patient has a chest x-ray with no signs of active lung disease within 60 days prior to treatment in this study. • The potentially fertile patient agrees to use an acceptable method of birth control throughout the study. Acceptable methods of contraception are defined as intrauterine device (IUD), diaphragm with spermicide, condoms or withdrawal.
Exclusion criteria
Exclusion criteria: • The patient does not meet the inclusion criteria for the protocol. • The female patient is pregnant or breastfeeding, or is hoping to conceive or donate her eggs during the study. The male patient is planning to fertilize or donate his sperm during the study. • The patient has used any investigating agent within the month prior to treatment in this study with the exception of direct ART agents that are available by expanding access, as described in Section I.E.l. Study Design Summary. • The patient has used another experimental HIV integrase inhibitor. • The patient has used immunosuppressive therapy within the month prior to treatment in this study. Short cycles of corticosteroids will be allowed (for example, as for an asthma exacerbation). • The patient requires or is expected to require any of the prohibited medications listed in the protocol. • The patient has a current (active) diagnosis of acute hepatitis due to any cause or chronic hepatitis that is not a stable chronic Hepatitis B and / or C. • The patient has a history of alcohol or other substance abuse that in the opinion of the investigator could interfere with patient compliance or safety. • The patient has any laboratory disorder or anomaly prior to the study, or a history of any disease, which, in the opinion of the researcher, could confuse the results of the study or pose an additional risk when administering the study drugs to the patient. • There is the inability to obtain a signed informed consent from a patient 18 years of age or older or when the parent / legal representative has granted consent, there is the inability to obtain the consent of a patient 16 or 17 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of participants who achieved HIV RNA <400 copies/mL at Week 16, 48, 156 and 240 Measure:Percentage of Participants Achieving HIV RNA <400 Copies/mL at Weeks 16, 48, 156 and 240 Timepoints:Weeks 16, 48, 156 and 240 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of participants who achieved HIV RNA 50 copies/mL or loss to follow-up; participants who never achieved HIV RNA <50 copies/mL on 2 consecutive visits are also considered as having loss of virologic response. Events are the numbers of participants with loss of virologic response versus the numbers of participants with no loss of virologic response (event free). Measure:Percentage of Participants Without Loss of Virologic Response Timepoints:156 weeks ; Outcome name:Mean change from baseline at Week 16 and 48 in HIV RNA (log10 copies/mL) Measure:Change From Baseline in HIV RNA (log10 Copies/mL) at Week 16 and 48 Timepoints:Baseline and Week 16 and 48 ; Outcome name:Mean change from baseline at Week 156 and 240 in HIV RNA (log10 copies/mL) Measure:Change From Baseline in HIV RNA (log10 Copies/mL) Timepoints:Baseline and Week 156 and 240 ; Outcome name:Mean change from baseline at Week 16, 48, 156 and 240 in CD4 Cell Count (cells/mm^3) Measure:Change From Baseline in CD4 Cell Count (Cells/mm^3) at Weeks 16, 48, 156 and 240 Timepoints:Weeks 16, 48, 156 and 240 | — |
Countries
Australia, Belgium, Denmark, France, Germany, Italy, Portugal, Spain, Switzerland, Taiwan, Thailand
Contacts
Public Contactstela lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed