None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with MK-0518 400 mg PO BID together with an optimal antiretroviral therapy chosen by the attending physician, for a period of 48 weeks.
Group name:GROUP 2 Type of group
This group will be treated with MK-0518 Placebo PO BID together with an optimal antiretroviral therapy chosen by the attending physician, for a period of 48 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient is a man or woman 16 years of age or older. 2. The patient has HIV RNA in plasma at the selection> 1000 copies / mL within 60 days prior to the treatment phase of this study. 3. The patient has been treated with ART and has had stable treatment with ART for months. 4. The patient has HIV with documented reduced susceptibility to at least one drug from each of the 3 authorized oral ART classes. 5. The patient had acceptable laboratory values within 35 days prior to the treatment phase of this study. 6. The patient has a chest x-ray without signs of active lung disease within 60 days prior to treatment in this study. 7. The patient with reproductive potential agrees to use an acceptable method of birth control throughout the study. Or The patient has no reproductive potential.
Exclusion criteria
Exclusion criteria: 1. Does not meet the inclusion criteria for the protocol. 2. The female patient is pregnant or nursing, or is waiting to conceive or donate their eggs during the study. The male patient is planning to fertilize or donate his sperm during the study. 3. The patient has used any agent under investigation within the month prior to treatment. 4. The patient has used another experimental HIV integrase inhibitor. 5. The patient has used an immunosuppressive therapy within the month prior to treatment in this study. 6. The patient requires or is expected to require any of the prohibited medications listed in the protocol. 7. The patient has a current (active) diagnosis of acute hepatitis or chronic hepatitis that is not a stable chronic Hepatitis B and / or C. 8. The patient has a history of abuse of alcohol or other substance that could interfere with the patient´s compliance or safety. 9. The patient has any laboratory disorder or anomaly prior to the study, or a history of any disease, which could confuse the results of the study or pose an additional risk when administering the study drugs to the patient. 10. There is an 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 and there is an inability to obtain the consent of the patient 16 or 17 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:PCR for HIV RNA in peripheral blood. Measure:Primary efficacy: Levels of HIV RNA. Timepoints:Day 1, weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, at follow-up 14 days after therapy or in case of failure or discontinuation of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Chest x-ray. 12-lead ECG. Laboratory tests: Chemical panel, blood panel, urine test, pregnancy test. Measure:Safety of the treatment. Timepoints:Clinical evaluation, laboratory tests: Day 1, weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, at follow-up 14 days after therapy or in case of failure or discontinuation of therapy. Chest x-ray: Before starting the treatment. 12-lead ECG: Before starting treatment, weeks 24 and 48 and during follow-up 14 days after therapy or in case of discontinuation of therapy. ; Outcome name:Peripheral blood measurement of CD4 levels according to central laboratory procedures. Viral resistance: Through commercial trials of Monogram Biosciences. Measure:Secondary efficacy: CD4 cell counts. Viral resistance Timepoints:CD4 cell counts: Day 1 and weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 and at the 14-day follow-up after therapy. Viral resistance: Weeks 24, 48 and in case of discontinuation. ; Outcome name:Concentration of MK-0518 in peripheral blood. Measure:Pharmacokinetics. Timepoints:Weeks 4, 8, 12, 16, 24 and 32. | — |
Countries
Australia, Denmark, France, Germany, Italy, Portugal, Spain, Switzerland, Taiwan, Thailand
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed