Treatment of primary HIV infection: a pilot study of stavudine and didanosine plus nevirapine with or without hydroxyurea.

Treatment of primary human immunodeficiency virus (HIV) infection (PHI) may provide an opportunity to achieve a long lasting suppression of viral replication. Although there is growing evidence of the benefit of treating PHI, clinical data are still very limited. Special therapeutic considerations in this clinical setting include the prevalence of resistant viruses in the community, complexity of regimens and their long-term toxicity. In addition, adjunctive therapies aimed at exploring the role of immune modulation and intensification of antiretroviral therapy are becoming areas of great interest. In this regard, the role of hydroxyurea, a cytostatic agent that potentiates the antiviral effect of didanosine, and possibly of stavudine is being investigated. A pilot study to assess the antiviral effect of a combination of didanosine plus stavudine plus nevirapine with or without hydroxyurea in the treatment of PHI is currently under way. Preliminary results on 22 patients who completed at least 36 weeks of therapy suggest that the combination is safe, well tolerated and effective for the treatment of PHI.