Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients. The purpose of a phase two trial is to see if the drug is effective at doing what the manufacturer claims it should do.
Researchers also watch closely for unexpected adverse reactions.
25 will be enrolled in each of 3 treatment groups. 48 weeks after the last patient is enrolled. Adequate hematology, renal, and liver function. Capravirine or any protease inhibitors. Any investigational agent, medications known to inhibit or induce cytochrome P450, cytotoxic chemotherapy, or immunomodulators within 28 days before the first dose of study drug.