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-Naive HIV Infected Patients - ND
- Conditions
- aive HIV-Infected Patients,MedDRA version: 9.1 Level: LLT Classification code 10000807 Term: Acute HIV infection
- Registration Number
- EUCTR2008-002733-70-IT
- Lead Sponsor
- MERCK & CO., INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 700
Patient is a male or female at least 18 years of age on the day of signing the informed
consent.
2. Patient is HIV positive as determined by a positive result by enzyme-linked
immunosorbent assay (ELISA) and has screening plasma HIV RNA (determined by
the central laboratory) >5000 copies/mL within 45 days prior to the treatment phase
of this study, and is indicated for treatment based on physician assessment. Local
treatment guidelines should be considered in the decision to initiate therapy.
3. Patient is naive to antiretroviral therapy (ART) or defined as having received <7 days
total of any ART.
Patient has the following laboratory values within 45 days prior to the treatment
phase of this study:
4.1 Serum creatinine ≤2.0 x upper limit of normal
4.2 Alkaline phosphatase ≤5.0 x upper limit of normal
4.3 AST (SGOT) and ALT (SGPT) ≤5.0 x upper limit of normal
Note: A single repeat of a laboratory screening test will be allowed for test results that
are unexpected based on documented prior laboratory results.
5. Patient has a calculated creatinine clearance at time of screening >30 mL/min, based
on the Cockcroft-Gault equation which is as follows (and 0.85X this value for
females):
Clcr (mL/min) = (140-age) x weight (in kg)
72 x serum creatinine (mg/dL)
6. In the opinion of the investigator, the patient should be considered clinically stable
with no signs or symptoms of active infection, at the time of entry into the study; i.e.,
clinical status and all chronic medications should be unchanged for at least 2 weeks
prior to the start of treatment in this study.
7. Patient who is of reproductive potential agrees remain abstinent or use (or have their
partner use) 2 acceptable methods of birth control throughout the study. Acceptable
methods of birth control are: oral contraceptives, intrauterine device (IUD),diaphragm with spermicide, contraceptive sponge, condom, vasectomy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patient has a history or current evidence of any condition, therapy, laboratory
abnormality or other circumstance that might confound the results of the study, or
interfere with the patient?s participation for the full duration of the study, such that it
is not in the best interest of the patient to participate.
2. Patient is, at the time of signing informed consent, a user of recreational or illicit
drugs or has had a recent history (within the last year) of drug or alcohol abuse or
dependence.
3. Patient has been treated for a viral infection other than HIV, such as hepatitis B, with
an agent that is active against HIV including but not limited to adefovir, tenofovir,
emtricitabine or lamivudine.
Note: Patients may be enrolled if treatment occurred prior to the diagnosis of HIV.
4. Patient has documented resistance to tenofovir, emtricitabine, and/or efavirenz.
5. Patient is currently participating or has participated in a study with an investigational
compound or device within 45 days of signing informed consent.
6. Patient has used another experimental HIV-integrase inhibitor.
7. Patient has used systemic immunosuppressive therapy within one month prior to
treatment in this study. Short courses of corticosteroids (e.g., as for asthma
exacerbation) will be allowed.
8. Patient requires hemodialysis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method