Randomized, double-blind trial comparing indinavir alone, zidovudine alone and indinavir plus zidovudine in antiretroviral therapy-naive HIV-infected individuals with CD4 cell counts between 50 and 250/mm3.

Treatment with indinavir has been shown to result in marked decreases in viral load and increases in CD4 cell counts in HIV-infected individuals. A randomized double-blind study to evaluate the efficacy of indinavir alone (800 mg q8h), zidovidine alone (200 mg q8h) or the combination was performed to evaluate progression to AIDS. 996 antiretroviral therapy-naive patients with CD4 cell counts of 50-250/mm3 were allocated to treatment. During the trial the protocol was amended to add lamivudine to the zidovudine-containing arms. The primary endpoint was time to development of an AIDS-defining illness or death. The study was terminated after a protocol-defined interim analysis demonstrated highly significant reductions in progression to a clinical event in the indinavir-containing arms, compared to the zidovudine arm (p<0. 0001). Over a median follow-up of 52 weeks (up to 99 weeks), percent reductions in hazards for the indinavir plus zidovudine and indinavir groups compared to the zidovudine group were 70% and 61%, respectively. Significant reductions in HIV RNA and increases in CD4 cell counts were also seen in the indinavir-containing groups compared to the zidovudine group. Improvement in both CD4 cell count and HIV RNA were associated with reduced risk of disease progression. All three regimens were generally well tolerated.

Listeriosis and AIDS: case report and literature review.

Listeriosis is a not uncommon infection in humans, usually associated with immunodeficient states and with newborns. However, relatively few cases have been reported in HIV-infected patients. This scarcity of reported cases has aroused interest in the association of listeriosis and AIDS. In this paper we present a case of meningitis and septicemia caused by Listeria monocytogenes in a female patient with AIDS. A review of recent medical literature indicates that association of listeriosis and AIDS may be more common than it seems. Recent research in host-parasite interaction in listerial infection suggests an important role for tumor necrosis factor (TNF) and for integralin, a bacterial protein, in modulating listerial disease in AIDS patients. Inadequate diagnosis may be in part responsible for the scarcity of reports.