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The Mycoses Study Group (MSG) is a self-governed organization with its own scientific agenda and process to determine what will be evaluated in its clinical trials. Non-MSG investigators wishing to evaluate potential therapies in the MSG must collaborate with MSG investigators.

The MSG is a collaborative network of academic and private research institutions conducting clinical trials for improved antimicrobial therapies for systemic fungal infections in immunocompromised patients, including HIV-infected and uninfected subjects. The MSG is comprised of investigators at 66 main and affiliate institutions and a Coordinating Center that provides operational support, data management, statistical consultation and analysis functions. The Coordinating Center is funded by the Division of Microbiology and Infections Diseases and the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID). The MSG coordinates its scientific agenda and often collaborates with the Adult AIDS Clinical Trials Group.

MSG Research Agenda

The MSG was established by NIAID in 1978 to conduct controlled clinical trials for improved antimicrobial prophylaxis and treatment of systemic mycotic infections. The MSG provides scientific expertise and access to patients with serious fungal diseases in order to evaluate established and experimental agents as potential therapies. Major studies have been conducted in the treatment or prevention of histoplasmosis, fluconazole-refractory candidiasis, and cryptococcosis, in AIDS patients. Sub-projects are configured around coccidioidomycosis, endemic mycoses, cryptococcosis, aspergillosis, and candidiasis occurring in HIV infected and non HIV infected populations.

Examples of clinical studies:

• A study to compare the safety and efficacy of AmBisome with conventional amphotericin B for induction therapy of histoplasmosis in patients with AIDS.
• A randomized double blind protocol comparing amphotericin B with flucytosine to amphotericin B alone followed by a comparison of fluconazole and itraconazole in the treatment of acute cryptoccoccal meningitis.
• A phase IV randomized study of the use of fluconazole as chronic suppressive therapy versus episodic therapy in HIV positive subjects with recurrent oropharyngeal candidiasis.
• A phase I evaluation of the safety and pharmacodynamic activity of a murine-derived anticryptococcal antibody in patients who have recovered from AIDS-associated cryptococcal meningitis.
• A prospective, randomized, double-blind trial comparing liposomal amphotericin B with fluconazole for prophylaxis of invasive fungal infections in liver transplant recipients at high risk for these infections and a prospective observational cohort study of liver transplant recipients at low risk for invasive fungal infection.
• A comparative trial of AmBisome versus amphotericin B in the empiric treatment of febrile neutropenic patients.
• A randomized, open-label, comparative multicenter trial of voriconazole versus AmBisome for empirical antifungal therapy in immunocompromised patients with persistent fever and neutropenia.

Accessing These Resources

Investigators wishing to have a therapy evaluated by the MSG should do the following:

1. Refer to the MSG research agenda above to determine whether the therapeutic concept is likely to be of interest to this group. If so:
2. Write a concept proposal in the appropriate format.
3. Submit the concept proposal to the DAIDS Therapeutics Research Program for review and forwarding to the MSG.

MSG's interest or disinterest in further pursuing the proposed concept will be relayed to investigators and additional information may be requested.