A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK- 0518 Versus Efavirenz in Treatment Naïve HIV-Infected Patients, Each in Combination With TRUVADA?

Phase 1

• Conditions: HIV Infection; MedDRA version: 14.1 Level: PT Classification code 10020162 Term: HIV infection CDC Group I System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2006-003109-23-ES
• Lead Sponsor: Merck Sharp and Dohme de España

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2012-02-24
• Study Start: 2012-08-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 550

Inclusion Criteria

1.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 60 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 naïve to ART.
4.Patient has the following laboratory values within 35 days prior to the treatment phase of this study:
4.1Serum creatinine ?2.0 x upper limit of normal
4.2Alkaline phosphatase ?5.0 x upper limit of normal
4.3AST (SGOT) and ALT (SGPT) ?5.0 x upper limit of normal
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 to use an acceptable method of birth control throughout the study. Acceptable method of birth control is defined as intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
OR
Patient who is not of reproductive potential ; is not sexually active, whose current partner(s) is/are not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception.
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 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.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 30 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.
9.Patient has significant hypersensitivity or other contraindication to any of the components of the study drugs.
10.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 and meet all inclusion criteria. Patients who, in the opinion of the investigator, have evidence of impairment of hepatic synthetic function, such as hypoalbuminemia or prolonged PT and PTT should be excluded.
11.Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified