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)

Status:	Completed
Conditions:	HIV / AIDS
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	5/3/2014
Start Date:	October 2012
End Date:	February 2016
Contact:	Toll Free Number
Phone:	1-888-577-8839

Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA Versus Efavirenz Plus TRUVADA in Antiretroviral Treatment-Naive, HIV-1 Infected Patients

Part 1 - Dose-Ranging. Part 1 will evaluate the (1) safety and tolerability and (2) efficacy
(antiretroviral activity) of 4 doses of MK-1439 compared with efavirenz, when each is given
in combination with TRUVADA® for at least 24 weeks in approximately 200 participants. A
single dose of MK-1439 will be selected for further study after all participants complete
the Week 24 visit in Part 1. Participants receiving any dose of MK-1439 in Part 1 will be
switched to the selected MK-1439 dose and continue in the study for up to 96 weeks.

Part 2 - Selected Dose. Part 2 will be initiated after the MK-1439 dose has been selected as
indicated above for Part 1. Approximately 120 additional participants will be randomized in
1:1 ratio to the selected dose of MK-1439 or efavirenz, each in combination with TRUVADA®
for 96 weeks of blinded treatment. Part 2 will evaluate the safety of the selected dose
compared with efavirenz, particularly with regard to central nervous system adverse events
(CNS events).

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

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

We found this trial at

sites

Clinical Trial Facility in Chapel Hill North Carolina

Chapel Hill, North Carolina

from

Chapel Hill, NC