A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK-0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA, in Treatment-Naïve HIV Infected Patients - Safety and efficacy of once daily raltegravir compared to twice daily raltegravir

Not Applicable

• Conditions: -B24 Unspecified human immunodeficiency virus [HIV] disease; Unspecified human immunodeficiency virus [HIV] disease; B24

• Registration Number: PER-124-08
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The patient is a man or woman at least 18 years of age on the day of signing the informed consent.
• The patient is HIV positive as determined by a positive result obtained in an enzyme-linked immunosorbent analysis (ELISA) and has a plasma HIV RNA in the selection (determined by the central laboratory)> 5000 copies / mL within 45 days prior to the treatment phase of this study, and it is recommended for treatment according to the doctor´s evaluation. Local paulas for treatment should be considered when deciding to start therapy.
• The patient has not undergone antiretroviral therapy or is defined as having received <7 days in total of any ART and no ART within 45 days prior to the treatment phase of this study.
• The patient has the following laboratory values ​​within 45 days prior to the treatment phase of this study: Serum creatinine <2.0 x normal upper limit, Alkaline phosphatase <5.0 x normal upper limit, AST (SGOT) and ALT (SGPT ) <5.0 x normal upper limit
• At the time of selection the patient has a creatinine clearance calculated> 30 mL / min, according to the Cockcroft-Gault equation,
• In the opinion of the researcher, the patient should be considered clinically stable and have no signs or symptoms of active infection, at the time of entering the study; that is, the clinical picture and all chronic drugs should not change for at least 2 weeks before the start of treatment in this study.
• The patient is potentially fertile and agrees to maintain abstinence or use (or have his partner use) two acceptable methods of birth control throughout the study. It is defined as acceptable methods of birth control: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condoms, vasectomy.

Exclusion Criteria

• 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 their participation throughout the study, so that the most convenient thing is not that the patient participant.
• At the time of signing the informed consent, the patient is a consumer of recreational or illegal drugs, or has had a recent history (within the last year) of drug or alcohol abuse, or dependence on such substances.
• The patient has been treated for a viral infection other than HIV, such as hepatitis B, with an agent that is active against HIV, including, without limitation, adefovir, tenofovir, emtricitabine or lamivudine.
• The patient has documented resistance to tenofovir and / or emtricitabine.
• The patient is currently participating or has participated in a study with a compound or device under investigation within 45 days of signing the informed consent.
• The patient has used another experimental inhibitor of HIV integrase.
• The patient has used systemic immunosuppressive therapy within the month prior to treatment in this study. Short cycles of corticosteroids will be allowed (for example, in cases of asthma exacerbation).
• The patient requires hemodialysis.
• The patient has significant hypersensitivity or other contraindication to any of the components of the study drugs.
• The patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and / or C, may enter the study as long as they have stable liver function tests, do not show significant impairment of hepatic synthetic function (defined as significant impairment of function Synthetic liver a serum albumin level <2.8 mg / dL or an INR> 1.7 in the absence of another explanation for the abnormal laboratory value) and meet all other inclusion criteria.
• The patient is pregnant or breastfeeding, or hopes to conceive (within the duration of the study). The patient hopes to donate eggs (within the duration of the study). The patient expects to donate sperm (within the duration of the study).

Study & Design

• Study Type: Interventional
• Study Design: Not specified