None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with MK-0518, in tablets, at a dose of 400 mg, PO, BID + Optimized Background Therapy (OBT), which consists of appropriate antiretrovirals, according to the treating physician s criteria. This scheme will be administered for 156 weeks.
Group name:GROUP 2 Type of group
This group will be treated with MK-0518 Placebo, in tablets, PO, BID + Optimized Background Therapy (OBT), which consists of appropriate antiretrovirals, according to the criteria of the attending physician. This scheme will be administered for 156 weeks.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient is a man or woman of at least 16 years of age. 2. The patient has HIV RNA> 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 ≥ 2 months before the selection. 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 potentially fertile patient agrees to use an acceptable method of birth control throughout the study. Or the patient is not potentially fertile; is not sexually active, whose current partner (s) is (are) not potentially fertile, or whose sexual activity is exclusively homosexual, is eligible without requiring the use of contraception.
Exclusion criteria
Exclusion criteria: 1. The patient 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 investigational agent within the month prior to treatment in this study. 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 diagnosis of acute hepatitis due to any cause 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, that 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Standard test COBAS AMPLICOR ™ HIV-1 Monitor, version 1.5. If the HIV RNA levels are below the quantification threshold, the COBAS Amplicor UltraSensitive Monitor, Version 1.5 test will also be used. Measure:Proportion of patients achieving HIV RNA in plasma <400 copies / mL. Timepoints:Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: The virological response can be determined according to one of the following: a) Either HIV RNA level <400 copies / mL or b) HIV RNA <50 copies / mL. RNA levels will be determined by the UltraSensitive® assay Criterion 2: COBAS AMPLICOR ™ HIV-1 Monitor standard test, version 1.5. Criterion 3: Peripheral blood count of CD4 + LT. Measure:1) Proportion of patients with virological response. 2) Change with respect to the baseline in HIV RNA (log10 copies / mL). 3) Change with respect to the baseline in the CD4 cell count. Timepoints:Week 16. ; Outcome name:Criterion 1: Determination of the time until the virological response criteria are lost (Described in criterion 2). Criterion 2: The virological response at week 48 is defined as: a) Either HIV RNA level <400 copies / mL or reduction from baseline in HIV RNA (log10 copies / mL) exceeding 1.0 log10 copies / mL; b) Level of HIV RNA <400 copies / mL; c) Level of HIV RNA <50 copies / mL; RNA levels will be determined by the UltraSensitive® assay. Criterion 3: COBAS AMPLICOR ™ HIV-1 Monitor standard test, version 1.5. Criterion 4: Peripheral blood count of CD4 + LT. Measure:1) Time to loss of virological response (TLOVR). 2) Proportions of patients with virological response at Week 48. 3) Change from baseline in HIV RNA (log10 copies / mL) at week 48. 4) Change from baseline in cell count CD4 in week 48. Timepoints:Week 48. ; Outcome name:Criterion 1: Clinical evaluation of any unfavorable and unintentional changes in the structure, function, or biochemistry of the body temporarily associated with the use of the research product. Criterion 2: Identification of any adverse event that: a) Causes death. b) It puts life at risk. c) Causes a persistent or significant disability / disability. d) Occurs or prolongs an existing hospitalization. e) It is a congenital anomaly / birth defect. f) It is a type of cancer. g) It is an overdose. Measur | — |
Countries
Australia, Belgium, Dominica, France, Germany, Italy, Portugal, Spain, Switzerland, Taiwan, Thailand
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed