Status Acronym ISRCTN EudraCT NCT (clinicaltrials.gov) DRKS
Active MK-1439-007-04 2012-001573-93 NCT01632345

A Dose-Ranging Study to Compare MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Human Immunodeficiency Virus (HIV)-1 Infected Participants (MK-1439-007)

Purpose / Objectives

Primary Outcome

Primary Outcome Measures:
  • Percentage of Participants with HIV RNA <40 copies/mL [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and for Part 1 and Part 2 combined
  • Number of Participants with any Clinical or Laboratory Adverse Event [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    Analyzed for Part 1 and for Part 1 and Part 2 combined
  • Percentage of Participants with CNS Events [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
    Analyzed for Part 1 and Part 2 combined
  • Percentage of Participants with CNS Events [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
    Analyzed for Part 1 and Part 2 combined

 

Secondary Outcomes

Secondary Outcome Measures:
  • Percentage of Participants with HIV RNA <200 copies/mL [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and for Part 1 and Part 2 combined
  • Change from Baseline in Cluster of Differentiation 4 (CD4) Cell Counts [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and for Part 1 and Part 2 combined
  • Percentage of Participants with HIV RNA <40 copies/mL [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and Part 2 combined
  • Number of Participants with any Clinical or Laboratory Adverse Event [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
    Analyzed for Part 1 and Part 2 combined
  • Percentage of Participants with HIV RNA <200 copies/mL [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and Part 2 combined
  • Change from Baseline in CD4 Cell Counts [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and Part 2 combined
  • Percentage of Participants with HIV RNA <40 copies/mL [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and Part 2 combined
  • Number of Participants with any Clinical or Laboratory Adverse Event [ Time Frame: 96 Weeks ] [ Designated as safety issue: Yes ]
    Analyzed for Part 1 and Part 2 combined
  • Percentage of Participants with HIV RNA <200 copies/mL [ Time Frame: 96 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and Part 2 combined
  • Change from Baseline in CD4 Cell Counts [ Time Frame: Baseline and 96 Weeks ] [ Designated as safety issue: No ]
    Analyzed for Part 1 and Part 2 combined

 

Diagnosis

  • HIV-1

Target population

Age

18-99

Inclusion criteria

  • HIV-1 positive
  • No previous use of antiretroviral therapy (ART)
  • No signs of active pulmonary disease within 45 days before the start of study treatment
  • Clinically stable with no signs or symptoms of acute infection
  • No change in clinical status or chronic medications for at least 2 weeks before the start of study treatment
  • Participants of reproductive potential agree to remain abstinent in line with their preferred and usual lifestyle or use (or have their partner use) 2 acceptable methods of birth control throughout the study and for 12 weeks post study.
  • Participants not of reproductive potential, not sexually active, whose current partner(s) is not of reproductive potential, or whose sexual activity is exclusively homosexual are eligible without requiring the use of contraception.

Exclusion criteria

  • Males planning to impregnate or provide sperm donation for the duration of the study plus an additional 12 weeks. Females pregnant or breast-feeding or expecting to conceive or donate eggs for the duration of the study plus an additional 12 weeks.
  • Received any approved or experimental antiretroviral agents or is anticipated to receive such medications during the study.
  • Use of any immunomodulators or immunosuppressive therapy within one month before the study. Short courses of corticosteroids (e.g., for asthma exacerbation) are allowed.
  • Treatment for a viral infection other than HIV, such as hepatitis B, with an agent that is active against HIV
  • HIV resistance to emtricitabine, tenofovir disoproxil fumarate, and/or efavirenz.
  • History of renal or urinary obstructive disease or requires dialysis
  • Active Hepatitis C virus (HCV) or Hepatitis B virus (HBV) co-infection
  • History of alcohol or other substance abuse
  • Participation in a study with an investigational compound/device within one month or is anticipating to participate in such a study during this study

Study design

  • Phase II
  • Multicenter
  • Five-arm
  • Double-blind
  • Randomized

Intervention

Arms Assigned Interventions
Experimental: MK-1439 25 mg

MK-1439 25 mg + TRUVADA®

Participants in this arm will receive MK-1439 25 mg in Part 1 and the selected MK-1439 dose (either 25 mg, 50 mg, 100 mg, or 200 mg) in Part 2.

These participants also receive placebo that matches efavirenz.

 Drug: MK-1439

Part 1: MK-1439 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) tablet or placebo matching MK-1439 orally every morning with or without food for at least 24 weeks

When the MK-1439 selected dose is determined after all participants reach Week 24, participants on other doses of MK-1439 will be switched to the selected dose for the remainder of the 96-week study.

Part 2: Selected dose of MK-1439 (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet or placebo matching MK-1439 orally every morning with or without food for 96 weeks

Drug: TRUVADA®
Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning alone or with MK-1439 or placebo matching MK-1439 for 96 weeks
Experimental: MK-1439 50 mg

MK-1439 50 mg + TRUVADA®

Participants in this arm will receive MK-1439 50 mg in Part 1 and the selected MK-1439 dose (either 25 mg, 50 mg, 100 mg, or 200 mg) in Part 2.

These participants also receive placebo that matches efavirenz.

 Drug: MK-1439

Part 1: MK-1439 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) tablet or placebo matching MK-1439 orally every morning with or without food for at least 24 weeks

When the MK-1439 selected dose is determined after all participants reach Week 24, participants on other doses of MK-1439 will be switched to the selected dose for the remainder of the 96-week study.

Part 2: Selected dose of MK-1439 (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet or placebo matching MK-1439 orally every morning with or without food for 96 weeks

Drug: TRUVADA®
Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning alone or with MK-1439 or placebo matching MK-1439 for 96 weeks
Experimental: MK-1439 100 mg

MK-1439 100 mg + TRUVADA®

Participants in this arm will receive MK-1439 100 mg in Part 1 and the selected MK-1439 dose (either 25 mg, 50 mg, 100 mg, or 200 mg) in Part 2.

These participants also receive placebo that matches efavirenz.

 Drug: MK-1439

Part 1: MK-1439 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) tablet or placebo matching MK-1439 orally every morning with or without food for at least 24 weeks

When the MK-1439 selected dose is determined after all participants reach Week 24, participants on other doses of MK-1439 will be switched to the selected dose for the remainder of the 96-week study.

Part 2: Selected dose of MK-1439 (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet or placebo matching MK-1439 orally every morning with or without food for 96 weeks

Drug: TRUVADA®
Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning alone or with MK-1439 or placebo matching MK-1439 for 96 weeks
Experimental: MK-1439 200 mg

MK-1439 200 mg + TRUVADA®

Participants in this arm will receive MK-1439 200 mg in Part 1 and the selected MK-1439 dose (either 25 mg, 50 mg, 100 mg, or 200 mg) in Part 2.

These participants also receive placebo that matches efavirenz.

 Drug: MK-1439

Part 1: MK-1439 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) tablet or placebo matching MK-1439 orally every morning with or without food for at least 24 weeks

When the MK-1439 selected dose is determined after all participants reach Week 24, participants on other doses of MK-1439 will be switched to the selected dose for the remainder of the 96-week study.

Part 2: Selected dose of MK-1439 (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet or placebo matching MK-1439 orally every morning with or without food for 96 weeks

Drug: TRUVADA®
Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning alone or with MK-1439 or placebo matching MK-1439 for 96 weeks
Active Comparator: Efavirenz

Efavirenz + TRUVADA®

Participants in this arm will receive efavirenz in Part 1 and in Part 2.

These participants also receive placebo that matches MK-1439.

 Drug: Efavirenz
Efavirenz 600 mg tablet or placebo matching efavirenz orally at bedtime taken without food on an empty stomach for 96 weeks
Drug: TRUVADA®
Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning alone or with MK-1439 or placebo matching MK-1439 for 96 weeks



Documents (password protected)

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Networks

  • MHH Klinik für Immunologie und Rheumatologie

Responsibilities in overall study

Sponsor

Merck Sharp & Dohme Corp.

  • Tel. +1 (908) 740-4000

(National) Coordinating Investigator

Prof. Dr. med. Matthias Stoll