Carolinas HealthCare System

Research and Clinical Trials

Brief Description   The purpose of this study is to evaluate the effectiveness, tolerability, and safety of the combination of etravirine 400mg with darunavir/ritonavir 800/100mg, all given once a day. In addition, this study will compare changes in cholesterol and blood sugar, along with changes in body fat, bone density, and markers of inflammation and immune function from Baseline (Day 1) to Week 48. Finally, the study will also assess the levels of these drugs in the body.
Who may be Eligible   Eligible patients must meet inclusion criteria and not have any of the exclusion criteria.

Inclusion criteria include: documented HIV infection, age 18 years or older, currently on HIV therapy with a viral load above 500, no more than 2 previous virologic failures while on PI-containing HIV regimens,demonstrated sensitivity to etravirine and darunavir, absense of specific mutations and a CD4 count greater than or equal to 50. Non-vasectomized heterosexually active male subjects must agree to use a barrier method of birth control during the trial and until 30 days after the end of the trial. Women of child bearing potential must agree to practice effective non-hormonal methods of birth control.

Exclusion criteria include:primary HIV-1 infection, previously documented HIV-2 infection, life expectancy less than 6 months, any current active AIDS defining illness (excluding cutaneous Kaposi's Sarcoma unlikely to require systemic therapy or Wasting syndrome if it is not actively progressive), acute viral hepatitis, hepatitis B infection (regardless of acuity or chronicity), concurrent participation in other clinical interventional trials, previously documented allergy or hypersensitivity to etravirine, darunavir or ritonavir, pregnant or breastfeeding female subjects or subjects who have previously received treatment with dapivirine, darunavir, enfuvirtide, etravirine, maraviroc, raltegravir, or rilpivirine.
Specialty/Disorder   HIV
IRBĀ Number   03-10-18B
PrincipalĀ Investigator   Johnson, Marc
For More Information, Contact   Jessica  A.  Kearney-Bryan , RN
Phone:  (704) 355-0244  Fax:  (704) 446-7641 
Address:  3rd Floor
Myers Park Clinic
1350 South King's Drive
Charlotte, NC 28207
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