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The analysis of pooled safety data from the pivotal phase three T-20 Versus Optimized Background Regimen Only (TORO) trials indicates that enfuvirtide is a well-tolerated antiretroviral agent with a maintained safety profile over 48 weeks in treatment-experienced HIV-1-infected adults. It is found that the rates of other adverse agents favored enfuvirtide or were generally comparable between treatments.

Exploratory analyses to compare treatment effects between the enfuvirtide and control groups by different factors after 48 weeks that were carried out are discussed. It was demonstrated that the efficacy to enfuvirtide is durable plus optimized background over 48 weeks.

Numerous potent antiretroviral regimens have proven successful as initial therapy in treatment-naive HIV-infected patients. As the development of new agents makes possible new treatment regimens, providers are faced with increasingly complex questions of when to initiate treatment and which regimen to select for individual patients. Clinical trial data provide a foundation for choosing an initial regimen and play a key role in the formation of treatment guidelines issued by the United States Public Health Service and other organizations. This paper reviews the results of recent clinical trials focusing on initial therapy and addresses important considerations when beginning antiretroviral therapy (ART) in treatment-naive individuals.

Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs) remain the backbone of highly active antiretroviral therapy (HAART). The pharmacokinetic properties, particularly those of the various phosphorylation steps, of the NRTIs/NtRTIs are reviewed.

A randomized, open-label, phase 3 study of enfuvirtide (T-20), a human immunodeficiency virus type 1 (HIV-1) fusion inhibitor was conducted through the T-20 vs. Optimized Regimen Only Study 1 (TORO 1). It was concluded that the addition of enfuvirtide to an optimized antiretroviral regimen provided significant antiretroviral and immunologic benefit through 24 weeks in patients who had previously received multiple antiretroviral drugs and had multidrug-resistant HIV-1 infection.

Research has been conducted on protease inhibitor atazanavir. The dose levels of this medication have been compared with those of nelfinavir as a monotherapy and in combination with didanosine and stavudine, and the results of this clinical trial carried out to compare safety, tolerability and antiretroviral efficacy of these three doses are reported.

The Zygomycetes are uncommon human pathogens. They cause illness in some patients who are immunosuppressed and can present as any of several syndromes, including rhinocerebral, pulmonary, gastrointestinal, or cutaneous disease, or as disseminated infection. Pulmonary zygomycosis can occur in any of several patterns and can mimic more common pneumonic processes. This mimicry, as well as the rarity of the disease, may delay diagnosis. We present a case of pulmonary zygomycosis that occurred in a patient who was a bone marrow transplant recipient. The case illustrates several of the common features of the disease in this patient group. (1995;88:1149-1152) Peter J. Piliero and Robert L. Deresiewiczs. Reprint requests to Dr Deresiewicz, Channing Laboratory, 180 Longwood Ave, Boston, MA 02115.