An intensive effort directed at improving the prevention and treatment of acquired immunodeficiency syndrome (AIDS)-associated opportunistic infections continues. HPMPC, a nucleotide analog with activity against cytomegalovirus (CMV) was studied, and a safe and possibly effective dose was identified for Phase III trials. CMVIG-IV (Cytogam) was evaluated for possible activity for the prevention of CMV; it did not decrease the ability to culture CMV from body fluids nor did it prevent disease caused by CMV supporting the notion that antibody is of minimal value in the treatment of active CMV infection. A Phase I/II study of sparfloxacin, an investigational quinolone agent, and azithromycin, a new macrolide agent for the treatment of infection caused by M. avium complex, was recently completed and data analysis is ongoing. A Phase I study of levofloxacin, an investigational quinolone agent that shows promise for the treatment of drug-resistant tuberculosis is almost complete. Enrollment in a study of interleukin-2 (IL-2) for the treatment of mycobacterial infection has begun. Studies of atovaquone, an agent with activity against Pneumocystis carinii, included completion of an assessment of the pharmacokinetics of the licensed tablet formulation of the drug and an assessment of the pharmacokinetics of an investigational suspension formulation of the drug; this suspension formulation was shown to be better absorbed than the tablet. In addition, a study of the efficacy and pharmacokinetics of the investigational suspension formulation of the drug for the treatment of pneumocystis pneumonia has just been completed, and data analysis is ongoing. The pharmacokinetics of dapsone and pyrimethamine were examined by using a population pharmacokinetic model. The assessment and follow-up of persons with idiopathic CD4+ T-lymphocytopenia (ICL) is continuing. Finally, a new outreach effort for the enrollment of women and members of minority and under-served populations in clinical trials has begun, which includes seeing patients in a local community health center. In addition, a major Request for Proposal has been issued to establish collaborations with minority institutions to assist Division of Intramural Research investigators in performing basic and clinical research studies related to M. tuberculosis.
