Safety and Efficacy of MK-1439A in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)
Status: | Active, not recruiting |
---|---|
Conditions: | HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/15/2017 |
Start Date: | January 14, 2016 |
End Date: | November 29, 2018 |
A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects With Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations
The primary objectives of this study are to evaluate the antiretroviral activity and to
evaluate the safety and tolerability of open-label MK-1439A consisting of a single
fixed-dose combination (FDC) tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil
fumarate 300 mg in treatment-naive HIV-1 infected participants with selected NNRTI
transmitted resistance mutations.
evaluate the safety and tolerability of open-label MK-1439A consisting of a single
fixed-dose combination (FDC) tablet of MK-1439 100 mg/lamivudine 300 mg/tenofovir disoproxil
fumarate 300 mg in treatment-naive HIV-1 infected participants with selected NNRTI
transmitted resistance mutations.
Inclusion Criteria:
- Is HIV-1 positive within 45 days prior to the treatment phase of this study, and have
HIV treatment indicated based on physician assessment.
- Is naïve to antiretroviral therapy (ART) including investigational antiretroviral
agents.
- Prior to screening, have had a genotype performed confirming the presence of only one
of the following NNRTI mutations: K103N, Y181C, or G190A.
- Is considered clinically stable with no signs or symptoms of active infection at 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).
- Is highly unlikely to become pregnant or to impregnate a partner
Exclusion Criteria:
- Is a user of recreational or illicit drugs or has had a recent history of drug or
alcohol abuse or dependence.
- 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.
- Has documented or known resistance to study drugs (MK-1439, lamivudine, and/or
tenofovir)
- Has participated or anticipates participating in a study with an investigational
compound/device within 30 days prior to signing informed consent
- Has any medical condition requiring, or likely to require, chronic systemic
administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other
immunosuppressant drugs during the course of the trial.
- Requires or anticipates requiring any of the prohibited medications
- Has significant hypersensitivity or other contraindication to any of the components
of the study drug
- Has a current (active) diagnosis of acute hepatitis due to any cause
- Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh
Class C score or Pugh-Turcotte (CPT) score > 9
- Is pregnant, breastfeeding, or expecting to conceive
- Is female and expecting to donate eggs, or is male and is expecting to donate sperm
at any time during the study
We found this trial at
9
sites
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