A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADA™, in Treatment-Naïve HIV-1 Infected Subjects

Not Applicable

• Conditions: -B20 Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases; Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases; B20

• Registration Number: PER-031-14
• 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: 2014-10-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Male or female ≥ 18 years of age
Understand and comply with study procedures, agree to participate by giving informed consent
HIV-1 + determined by enzyme-immunoassay, have screening plasma HIV-1 RNA
Naïve to antiretroviral therapy including investigational antiretroviral agents
Have the following screening laboratory values:
Serum creatinine ≤2.0 x ULN
Alkaline phosphatase ≤3.0 x ULN
AST (SGOT) and ALT (SGPT) ≤5.0 x ULN
Has a creatinine clearance ≥ 30 mL/min at time of screening
Be considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study
Agree to one of the following if of reproductive potential :
True abstinence: Abstinence is in line with the preferred and usual lifestyle of the subject
Use of an acceptable method of birth control throughout the study. Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy

Exclusion Criteria

History or current condition, therapy, lab abnormality or other circumstance that might confound the results of the study
User of recreational/illicit drugs or recent history of alcohol abuse
Treated for a viral infection other than HIV-1, such as Hep B, with an agent active against HIV-1
Known resistance to raltegravir, emtricitabine and/or tenofovir prior to treatment phase
Participated in a study with an investigational compound/device within 30 days of signing informed consent or anticipates participating in a study involving it/them during the study.
Used systemic immunosuppressive therapy or immune modulators within 30 days prior to study med or is anticipated to need them during the study
Requires or will require prohibited med:
Ca, Mg and Al containing antacids
Inducers of CYP3A4, including phenobarbital, phenytoin, rifampin, or rifabutin.
Hypersensitivity/contraindication to any component of study drugs
Current diagnosis of acute hepatitis due to any cause. Chronic Hep B and C may enter if they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function
Pregnant, breastfeeding, or expecting to conceive during the study.
Female expecting to donate eggs or male expecting to donate sperm during the study
Has immediate family member who is site or SPONSOR staff directly involved in this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified