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 + Lopinavir / Ritonavir (KALETRA) Placebo, in tablets, PO, BID
GROUP 2 Type of group
This group will be treated with Lopinavir / Ritonavir (KALETRA), in tablets, at a dose of 400/100 mg, PO, BID + MK-0518 Placebo, PO, IDB
this scheme will continue for up to 48 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 18 years of age. 2. The patient is HIV positive. 3. The patient has a documented HIV RNA 50 copies / mL during this time. 4. The patient has no history of coronary artery disease. 5. The patient has the following laboratory values ​​within 35 days prior to the treatment phase of this study: a) Alkaline Phosphatase ≤ 5.0 x normal upper limit. b) AST (SGOT) and ALT (SGPT) ≤ 5.0 x normal upper limit. 6. The patient does not present clinical evidence of active lung disease. 7. The patient is potentially fertile and agrees to use an acceptable method of contraception throughout the study. Or, the patient who is not potentially fertile; is not sexually active, whose current partner (s) are not / are potentially fertile, or whose sexual activity is exclusively homosexual is eligible without the use of contraceptive methods. 8. The patient agrees not to take the concomitant prohibited drugs.
Exclusion criteria
Exclusion criteria: 1. The patient is receiving a regimen based on KALETRA as a component of background antiretroviral therapy. 2. The patient is receiving a regimen based on KALETRA that includes a second protease inhibitor in addition to KALETRA. 3. The patient is currently receiving, or has received in the last twelve weeks, agents that are known to have an effect on lipid levels. 4. The patient has a medical history that includes diabetes mellitus. 5. The patient has a current history or evidence of any condition, therapy, laboratory abnormality or other circumstance that could confuse the results of the study, or interfere with the patient´s participation throughout the study. 6. The patient has a history of alcoholism or abuse of other substances that could interfere with the patient´s compliance or safety. 7. The patient is currently participating or has participated in a study with a compound or device under investigation within 30 days of signing the informed consent. 8. The patient has ever used any experimental inhibitor of HIV integrase. 9. The patient has used a systemic immunosuppressive therapy within one month before treatment in this study. 10. The patient requires hemodialysis. 11. The patient has significant hypersensitivity or another contraindication to any of the components of the study drugs. 12. The patient has chronic hepatitis. 13. The patient is pregnant or breastfeeding, or expects to conceive. The patient is estimating to donate ova. The patient is estimating to donate sperm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Serum levels of HIV-1 RNA will be measured by the Ultrasensitive AMPLICOR ™ HIV-1 Monitor (version 1.5). In cases where a patient has an HIV RNA> 50 copies / mL, a confirmatory HIV RNA will be made in about a week to confirm the virological relapse. Measure:Proportion of patients with plasma HIV RNA <50 copies / mL. Timepoints:Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Serum levels of HIV-1 RNA will be measured by the Ultrasensitive AMPLICOR ™ HIV-1 Monitor (version 1.5). In cases where a patient has an HIV RNA> 50 copies / mL, a confirmatory HIV RNA will be made in about a week to confirm the virological relapse. Criteria 2 and 3: T lymphocyte counts, CD-4. Measure:Secondary efficacy: 1) Proportion of patients with HIV RNA <50 copies / mL at Week 48. 2) Change from baseline in CD4 cell counts at Week 24. 3) Change from baseline in CD4 cell counts in Week 48. Timepoints:Criteria 1 and 3: Week 48. Criterion 2: Week 24. ; Outcome name:Peripheral blood levels of total cholesterol, triglycerides, non-HDL-C and LDL-C. Measure:Safety: Average changes with respect to the baseline in lipid profile values. Timepoints:Weeks 12, 24 and 48. | — |
Countries
Australia, Brazil, Colombia, India, Mexico, South Africa, Thailand, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed