Prescribing drug therapy for children is often more difficult than prescribing for adults because children respond to drugs differently at different ages and because oral medication must have an acceptable taste to children so that they will take it as prescribed.

In June 2007 the U.S. Food and Drug Administration (FDA) listed twenty-six drugs used to treat pediatric HIV patients. Nine of these, called protease inhibitors (PIs; used alone or in combination with other drugs to combat viral infection) were available for children two to thirteen years old. However, safety and effectiveness had not been established for four of the PIs: tipranavir, saquinavir mesylate (SQV), darunavir, and atazanavir sulfate. The PIs approved for use and deemed safe and effective by the FDA were amprenavir, nelfinavir, ritonavir, fosamprenavir calcium, and lopinavir/ritonavir. PI compounds act by preventing the reproduction of HIV that is already in the host cells.

Another group of drugs approved for pediatric use are known as nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs, which are structurally similar to a nucleoside constituent of deoxyribonucleic acid (DNA), limit HIV replication by incorporating themselves into a strand of DNA, which causes the chain to end. The NRTIs approved for pediatric use were:

-           Lamivudine

-           Emtricitabine

-           Abacavir

-           Zalcitabine and dideoxycytidine

-           Zidovudine

-           Tenofovir disoproxil fumarate

-           Enteric-coated didanosine

-           Didanosine and dideoxyinosine

-           Tenofovir disoproxil/emtricitabine

-           Stavudine

Another group of antiretroviral drugs are known as nonnucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs slow down the functioning of the enzyme that allows the virus to become a part of the infected cell's nucleus. Three NNRTIs are presently approved for pediatric use:

-           Delavirdine

-           Efavirenz

-           Nevirapine

In March 1996 the Antiviral Drugs Advisory Committee of the FDA approved the use of the compound didanosine for pediatric use. The approval was based on the results of two separate U.S. AIDS Clinical Trials Group pediatric studies (one of which was the largest controlled pediatric trial to date) and an Australian study, all of which found that didanosine delayed the progression of AIDS and was superior to ZDV alone. ZDV, which is given to children and adults, had been the only drug widely recognized to help delay the progress of HIV infection and to reduce the risk of perinatal infection.

The study results generated high expectations for the performance of didanosine in both children and adults. Indeed, the didanosine and combination therapies were so much more effective than ZDV alone that the AIDS Clinical Trials Group prematurely discontinued the ZDV-only therapy portion of the study. As promising as these early reports seemed, the effectiveness of didanosine alone or in combination with ZDV was short-lived because HIV susceptibility to the drugs decreased over time. Thus, even though didanosine is still used, it has not proven to be a major breakthrough in HIV infections as was hoped.

In 1999 a study conducted jointly by the United States and Uganda demonstrated that the perinatal transmission of HIV from mother to child could be reduced by the drug nevirapine. The drug is given to the mother in labor and to the child within three days of birth. Initial study results showed the drug to be safe for both mother and child and relatively inexpensive ($4 per mother/child dose). In 2000 the Elizabeth Glaser Pediatric AIDS Foundation, a nonprofit organization dedicated to promoting and funding worldwide pediatric AIDS research, secured funds to implement this treatment in developing countries that lack health-care resources and infrastructure.

By 2003 the administration of nevirapine to hundreds of thousands of pregnant women in Africa demonstrated the therapeutic potential of the drug in slowing the progression of pediatric AIDS. The WHO, governments throughout sub-Saharan Africa, and the U.S. National Institutes of Health have all recommended that nevirapine use be continued to prevent HIV transmission from mothers to infants.

Also in 2003 the drug enfuvirtide was approved for use by children over the age of six. This drug is the first of the fusion inhibitor class of antiretroviral drugs. It acts by inhibiting the fusion of HIV to the host cell membrane.

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