This is a multicenter, open-label study to evaluate the activity and safety of MK-0639 (Indinavir Sulfate) at 800 mg q8h, in combination with Zidovudine (200 mg q8h) and 3TC (150 mg BID), in patients with acute HIV-1 infection. Twelve individuals were recruited for this trial and initiated therapy within three months of HIV-1 exposure. Eleven patients are presently on study. Thus far, all patients have experienced significantly diminished viral load. In selected subjects, sigmoidoscopy biopsy of gastrointestinal-associated lymphoid tissue has been obtained for culture and in situ hybridization for HIV-1 RNA and RNA/DNA PCR. Preliminary results indicate absence of viral replication in subjects treated for 8-10 months. The need for additional fluid and tissue sampling is being evaluated. Results thus far suggest that early intervention with potent antiretroviral therapies in newly infected HIV-1 subjects could significantly alter the natural history of HIV-1 infection both virologically and immunologically. Immunologic responses to therapy, both humoral and cellular (CTL), are being studied. Also, VB repertoire and naive/memory subsets will be determined to assess the recovery capacity of the immune system post therapy in both acute and chronic infection. The testing of eradication remains a goal. Those patients who complete the 52 weeks of this study and whose viral RNA becomes negative or falls below the level of detection may enroll in an open-label extension phase of this trial. This will allow for continued assessment of the antiretroviral effect and evaluation of drug safety.
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