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

• Status: Completed
• Trial end date: 2016-03-21
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis tested in this study is that doravirine (MK-1439) at the final dose selected is superior to efavirenz, each given in combination with TRUVADA®, as measured by the percentage of participants with CNS events by Week 8. If superiority is established at Week 8, the same hypothesis will be tested for Week 24.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Efavirenz; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

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