Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) active against HIV-1 with demonstrated potency in treatment-experienced patients and potent short-term activity in treatment naïve patients reducing plasma HIV RNA. To date, etravirine has not been evaluated as part of combination antiretroviral therapy for naive patients initiating treatment for HIV infection.
Who may be Eligible
TREATMENT INDICATIONS (unable to load to section above): HIV positive subjects who are over 18 years of age and have taken less than or equal to 10 days of prior antiretroviral therapy.
WHO MAY BE ELIGIBLE: Subjects must have a viral load of greater than 1,000 within 90 days of the study and have a stable hematologic and chemistry profile. They must not have certain resistant mutations of the HIV virus. Subjects must not have previously taken etravirine, dapivirine, or rilpivirine. They cannot have acute viral hepatitis or have used an immune modulating drug within 30 days of study entry. If a subject has any current active illness requiring systemic treatment and/or hospitalization it must be clinically stable on therapy for at least 7 days prior to study entry. Pregnancy and breastfeeding women are excluded. Women of reproductive potential must agree to contraception use.