To determine whether adding 1 or 2 drugs to the current initial antiretroviral regimen is an effective strategy for treating the first viral rebound in patients who are able to complete 24 weeks of therapy with an intensified regimen. Intensification of the existing regimen by adding 1 or 2 drugs generally has been avoided. However, successfully adding new drugs to an existing regimen would be advantageous since it would expose the patient to fewer antiretroviral agents in the overall treatment course. Other studies have shown that treatment decisions based on resistance assays result in better virologic outcomes.
Patients undergo phenotypic drug resistance testing prior to study entry.
A patient is excluded from randomization to an arm if that arm contains a drug to which the patient has phenotypic resistance. A patient's HIV must be sensitive to at least 3 drugs. Patients have regular clinic visits for physical exams and blood tests, including CD4 and CD8 cell counts, plasma HIV-1 RNA assays, and tests for pharmacokinetic variability. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients.