Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Treatment Intensification for HIV Infected Patients With Multi-Drug Resistant Virus
Drug resistance may develop in HIV infected patients who take anti-HIV drugs, but most
 patients do well if they continue taking them. The purpose of this study is to test the
 effectiveness of a short, intensified course of anti-HIV drugs for controlling HIV infection
 in adults who have virus resistant to multiple drugs.
While an HIV infected patient is taking highly active antiretroviral therapy (HAART),
 drug-resistant HIV may emerge; however, it has been observed that HIV viral loads while on
 HAART are usually lower than baseline levels. Expansion of the T cell population during early
 HAART may explain this phenomenon. It is hoped that a short but aggressive HAART regimen to
 treatment-experienced patients who have drug-resistant virus will produce immune cells that
 will better control drug-resistant virus. This study will determine if a 6-month HAART
 regimen intensified by enfuvirtide (T-20) is effective in eliciting a stronger immune
 response against drug-resistant virus.

 This study will last 48 weeks. All participants will receive T-20 as part of a HAART
 intensification regimen; HAART other than T-20 will not be provided by the study. There will
 be 17 study visits. Prior to beginning treatment intensification, participants will have
 weekly study visits for three weeks. Once treatment intensification has started, participants
 will be followed weekly for four weeks, then weekly for four weeks after treatment
 intensification, then monthly thereafter. Blood collection will occur at each visit.
Inclusion Criteria:

 -  HIV viral load of more than 1000 copies/ml

 -  On stable antiretroviral therapy

 -  Have multidrug resistance

 Exclusion Criteria:

 -  Require immunomodulatory drugs