ACTG 372 - A Phase II Study of the Prolongation of Virologic Success and Options for Virologic Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320. The purpose of this study is 1) to determine how many people will have an undetectable amount of plasma HIV (less than 500 copies/ml) by week 16; 2) to determine the length of time that plasma HIV levels remain less than 500 copies/ml; and 3) to establish if these drugs are safe to take in combination and how well they are tolerated. This study will use zidovudine (ZDV), stavudine (d4T), lamivudine (3TC), didanosine (ddl), nelfinavir (NFV), abacavir (1592U89), adefovir dipivoxil, L-carnitine, efavirenz (DMP-266), and indinavir. Indinavir, nelfinavir, and abacavir (1592U89) are FDA approved protease inhibitors. Efavirenz (DMP-266) is an FDA approved anit-HIV drug. Adefovir dipivoxil is still considered investigational. Early studies have shown that these drugs may be helpful in preventing HIV from multiplying in the body. In order to be screened for participation in this study, the individual must be taking ZDV (or d4T) and 3TC with indinavir (IDV) for at least three months prior to and up to the time of the study. The individuals HIV RNA level (amount of HIV in the blood) must be more than 500 copies/mL. All study drugs will be given by mouth. Approximately 440 subjects will be recruited at multiple sites.
Showing the most recent 10 out of 1065 publications
