other members of the household as well. Of the 2,000 people enrolled as of November 2003, one-third were children, and one-fifth were partners of the (index) women.

The programs target people at the earlier stages of disease. The mean CD4 count of patients beginning treatment is 379. The index women are at a less advanced stage of disease than their partners who become enrolled. Most of the infants enrolled in the program are of indeterminate status; they are followed clinically as an effort to provide comprehensive family care.

Each MTCT-Plus site uses standardized protocols with respect to treatment eligibility criteria, treatment monitoring, toxicity management, drug regimens, and pediatric dosing. An attempt is made to harmonize these protocols with both country-specific and WHO guidelines. The antiretrovirals (ARVs) used in these programs are procured by UNICEF; approximately half are generic products.

CLINICAL PRINCIPLES

Because of the complexity of HIV and AIDS, WHO established clinical guidelines in 2003 as part of its 3-by-5 campaign (see Chapter 2) to assist programs in scale-up of ART (WHO, 2003b). These guidelines take into account experience gained in the clinical management of HIV/AIDS in the developed world and lessons learned from treating the disease in the developing world. Data from clinical trials and observational studies underlie the guidelines.

In recognition of the limitations faced by resource-constrained settings, such as cost and availability of drugs and diagnostics, the WHO guidelines offer suggestions specific to these settings. The guidelines provide a framework that can be used to standardize and simplify treatment for this complex disease and encompasses the point at which to start therapy; first- and second-line combination regimens; considerations involved in treating subgroups of patients, such as those coinfected with TB, pregnant women, and children; means of monitoring therapy; and indicators for changing regimens. As noted earlier, these recommendations are based on scientific and clinical experience and evidence, drug availability and cost, the requirement to refrigerate some ARVs, the need for and availability of laboratory monitoring, drug toxicity profiles, and the risk of drug interactions. The guidelines acknowledge limitations in areas in urgent need of research, such as the treatment of pregnant women and individuals coinfected with TB. Nonetheless, they provide a critically important starting point by outlining simple criteria and steps that can be used in even the most resource-poor settings.

The WHO guidelines can be used by providers with a range of experience in diagnosing and treating people with HIV/AIDS. The simplified,



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