MK-1439A once a day versus ATRIPLA once a day in treatment-naïve HIV-1 infected subjects

Phase 1

• Conditions: Human Immunodeficiency Virus-1 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 18.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862

• Registration Number: EUCTR2014-003382-17-NL
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-12
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

1.be at least 18 years of age on the day of signing the informed consent
2.understand the study procedures and voluntarily agree to participate by giving written informed consent (or have a legal representative provide written informed consent if considered acceptable by local regulatory agencies and/or ERCs/IRBs) for the trial. The subject or his/her legal representative (if considered acceptable by local regulatory agencies and/or ERCs/IRBs) may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
3.be HIV-1 positive as determined by a positive result on an enzyme-immunoassay, have screening plasma HIV-1 RNA (determined by the central laboratory) =1000 copies/mL within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
4.be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
5.have the following laboratory values at screening within 45 days prior to the treatment phase of this study: a) Alkaline phosphatase =3.0 x upper limit of normal b)AST (SGOT) and ALT (SGPT) =5.0 x upper limit of normal c) calculated creatinine clearance at the time of screening = 50 mL/min; d) Hemoglobin =9.0 g/dL (if female) or =10.0 g/dL (if male).
6.clinically stable with no signs or symptoms of active infection at the time of entry into the study.
7.be highly unlikely to become pregnant or to impregnate a partner.
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 675
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1.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 subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
2.is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. The nature and potential clinical context of the subject's illicit drug use, in relation to their exclusion from this trial, will be at the discretion of the Investigator.
3.has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
4.has documented or known resistance to study drugs including MK-1439, efavirenz, emtricitabine, lamivudine, and/or tenofovir, as defined below:
a.Resistance to MK-1439 or efavirenz for the purpose of this study includes the following NNRTI mutations: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, P225H, F227C, F227L, F227V, M230L, M230I
b.Resistance to emtricitabine, lamivudine and tenofovir includes the following mutations: K65R, M41L, T69S (insertion complex), Q151M, M184I, M184V, L210W, T215F, T215Y, K219E, K219Q, D67N, K70R and K70E.
5.has participated in a study with an investigational compound/device within 30 days prior to signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study.
6.has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study.
Note: Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
7.requires or is anticipated to require any of the prohibited medications noted in the protocol.
8.has significant hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator.
9.has a current (active) diagnosis of acute hepatitis due to any cause.
10. has evidence of decompensated liver disease or liver cirrhosis
11.is pregnant, breastfeeding, or expecting to conceive.
12.is female and is expecting to donate eggs (at any time during the study) or is male and is expecting to donate sperm (at any time during the study).
13.is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.

Study & Design

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