EMEMD
A
Phase 1B, Randomized, Placebo Controlled, Double Blind
Study to Determine the Safety, Viral Suppression Potential,
Pharmacokinetics and Immune Modulatory Effects of
the Treatment with Aprepitant (EMEND) in HIV Infected
Patients
Purpose of this Study: This is
randomized,
placebo controlled, double blind study to determine
the safety and antiviral activity of Aprepitant (EMEND)
by comparing the change in HIV RNA viral load after
2 weeks of aprepitant monotheraphy.
Requirements to Enter Study:
- Subject is antiretroviral-naive or off therapy
within 16 weeks prior to entry.
- HIV-1 RNA > 2,000
- CD4 > 350
- Laboratory values (obtained at screening):
AST, ALT, ALP < 2xULN, Tbili <
2.5xULN,ANC > 750/mm3, Hgb >
10 g/dL, PLT > 100,000, CRET <
2xULN, Alb > 3g/dL, Lipase <
1.5x ULN
- Men and Women > 18
- CCR5 tropic done at screening
- Various medical and medication restrictions
- Study nurse will evaluate.
Treatment: Subjects randomized
1:1:1
Arm A: Aprepitant Placebo
Arm B: Aprepitant 125 mg QD
Arm C: Aprepitant 250 mg QD
Duration of Study: 42 days
For
more information contact:
Study
Contacts
Wayne
Wagner, RN (215) 349-8092
