American Journal of Law & Medicine

The under-enrollment of HIV-infected foster children in clinical trials and protocols and the need for corrective state action.


The incidence of HIV infection and AIDS in children has grown at an alarming rate. Approximately one million children worldwide have HIV infection.(1) By the year 2000, an estimated ten million children will suffer from the disease.(2) Currently, the United States has a population of an estimated 10,000 to 20,000 HIV-infected children.(3) As of June 30, 1993, the Centers for Disease Control and Prevention (CDC) reported 4,710 known AIDS cases in children twelve years-old and younger.(4) At that point, New York City reported 1,124 pediatric AIDS cases which represented twenty-four percent of all cases in the United States.(5)

With the rising number of HIV-infected children, the medical community in the United States has begun to search for HIV- and AIDS-related treatments particularized for children. In addition to establishing guidelines for HIV-infected children's frequent check-ups and timely immunizations, the medical community has initiated research studies involving HIV-infected children.(6) Through such studies, investigators have begun to determine which drugs and which combinations of drugs prove most effective in slowing or preventing the progression of AIDS and AIDS-related illnesses in children.(7) Producing many benefits to participants,(8) HIV- and AIDS-related research studies have enrolled a significant number of HIV-infected children. As of October 8, 1993, the AIDS Clinical Trials Group (ACTG), a network of fifty-two medical centers conducting studies sponsored by the National Institute of Allergy and Infectious Diseases (NIAID),(9) had enrolled 3,154 children under the age of thirteen in various research studies.(10)

However, very few of the HIV-infected children enrolled in research studies are in foster care.(11) A nationwide survey of state child protection agencies conducted between February and August 1989 revealed that less than two percent of foster children diagnosed as HIV positive were participating in clinical trials.(12) Since 1989, the enrollment of HIV-infected foster children has improved only slightly. In New York City, for example, investigators had enrolled only 124--twenty percent--of approximately 618 HIV-infected foster children in clinical trials or protocols(13) by September 30, 1993.(14) Although it has a dismally low enrollment rate of HIV-infected foster children, New York City is one of the few cities or states to authorize the enrollment of foster children in research studies.(15)

This Article examines the participation of HIV-infected foster children in related research studies and concludes that state legislatures should take an active role in expanding foster children's opportunities to participate in research. The Article focuses primarily on the enrollment of HIV-infected foster children in New York City where almost a quarter of all pediatric AIDS cases in the United States have been reported and which reports approximately 49,000 children in foster care.(16) The Article first discusses the benefits and importance of HIV-infected children's participation in research studies. Next, the Article describes federal regulations applicable to research involving children. The Article then examines the barriers to foster children's participation in research studies and critiques the initiatives of New York City and several states to enroll HIV-infected foster children in clinical trials and protocols. In the final section, the paper proposes state legislation to ensure foster children's participation in HIV- and AIDS-related clinical trials and protocols.


The anticipated benefits of each particular study constitute the most obvious benefits to children participating in HIV- and AIDS-related research. To date, HIV-infected children enrolled in various studies have realized many anticipated benefits.(17) For example, investigators have shown that zidovudine (AZT), a drug that slows HIV replication, improves the condition of symptomatic HIV-infected children who exhibit poor growth and delayed cognitive and motor development.(18) Investigators also have shown that the drug didanosine (ddI) may prevent neurological impairment in HIV-infected children.(19) Finally, in a double-blind placebo-controlled study of intravenous immunoglobulin (IVIG), investigators demonstrated that IVIG reduces secondary bacterial infections, such as meningitis, osteomyelitis, pneumonia, and internal-organ abscess, in HIV-infected children.(20)

Although the anticipated benefits of a particular study may fail to materialize, HIV-infected children enrolled in research gain other important benefits from their participation. Perhaps the greatest positive consequence to HIV-infected children participating in research is access to the best available treatment. In a 1988 report, the Secretary of the Department of Health and Human Services found that HIV-infected children receive "state-of-the-art care" only in investigational treatment programs.(21) The Secretary concluded that although manufacturers usually market investigational drugs that prove successful in treating HIV-infected children, children outside of the clinical research setting have no guaranteed access to these drugs.(22) Furthermore, investigators usually guarantee HIV-infected children continued access to a treatment that proves effective as a condition of their participation in research.(23) Unlike most HIV-infected children, children enrolled in clinical trials and protocols also undergo frequent medical examinations. During these examinations, physicians and investigators familiar with the progression of HIV infection and AIDS can detect complications and illnesses at an early stage and provide appropriate treatment.(24) HIV-infected children enrolled in research gain additional benefits of early and continued access to new therapies and the early detection and treatment of related illnesses.

Benefits accrue to the public as well as to individual children involved in research. In a report issued in 1977, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research declared that the lack of a comparable testing population and the lack of properly tested treatments for children justify their participation as research subjects.(25) Because children's physiology differs dramatically from that of animals or adult humans, results from animal or adult human research remain inconclusive as to children.(26) The deaths and disabilities of children resulting from the administration of various drugs prior to any pediatric investigation underscore the tremendous risks of treating children on the basis of extrapolations from research on adult humans.(27) The participation of children in research also reduces the "`therapeutic orphan' phenomenon" in the United States caused by investigators' failure to test most drugs for safe and effective use in children.(28)

HIV- and AIDS-related research involving children has produced tremendous benefits for all HIV-infected children. Since 1990, the Food and Drug Administration (FDA) has allowed physicians to prescribe AZT for children over three months old.(29) Based on the demonstrated effectiveness of ddI, the FDA also has approved its use in children who do not respond well to AZT.(30) Using research results showing that children have more immune system cells, known as CD4+ T-cells, than adults, the Centers for Disease Control has established guidelines for the prophylaxis of Pneumocystis carinii pneumonia (PCP) in 1991.(31) These guidelines recommend the administration of a combination of trimethoprim and sulfamethoxazole (TMP/SMX) adjusted for a child's age and CD4+ count.(32)

As investigators continue to search for more effective combinations of drugs and safer dosages of available drugs for use in HIV-infected children, the public stands to gain even more benefits from research involving HIV-infected children. Currently, investigators sponsored by the NIAID are conducting studies to determine:

1) whether children, like adults, will benefit from a lower dose of AZT

than that presently recommended;

2) whether children born HIV-infected will benefit from anti-HIV

therapy administered during the first three months of life when

they experience the greatest replication of HIV;

3) whether children will react better to the administration of anti-HIV

drugs, such as ddI, zalcitabine (ddC), alpha interferon and

neviraphine, solely or in combination with each other or AZT;

4) whether children taking lower doses of anti-HIV drugs in combination

will experience fewer side effects and yet benefit from the

treatment; and

5) whether children who suffer from PCP and who cannot take TMP/

SMX will benefit from steroid therapy and other possible


In several studies aimed at reducing the transmission of HIV infection from mothers to newborns, investigators also are examining the effect of HIV vaccines in HIV-infected children and pregnant women.(34)


Children infected with HIV should participate in HIV- and AIDS-related research to increase their individual longevity. Following diagnosis, HIV-infected children have a greatly shortened life span. Infants diagnosed with HIV infection before their first birthdays have a median survival rate of six months after diagnosis.(35) Perinatally infected children diagnosed after their first birthdays have a median survival rate of thirty-eight months.(36) As discussed above, HIV-infected children gain access to life-prolonging therapies through their participation in research.(37)

HIV-infected children also should participate in clinical trials and protocols to ameliorate the effects of AIDS-related illnesses. …

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