ICC Investigation – The ICC Website and Clinical Trials

Evidence in the New York Orphans in Government Drug Trial Investigation

The following is evidence in the long-running investigation into the use of toxic drugs on orphans in New York City in the Incarnation Children’s Center orphanage and in New York’s major hospitals, and then in Aids medicine in general.

Background on this story – here and here.

Below is the ICC webpage as it appeared when I first looked at it, in 2003. It was taken down in early 2004, after press attention focused on the practice of using orphans in government and pharma-sponsored drug trials.

The page announces the clinical trials then in progress, as well as making some strong statements about improvement of patient health without the admittedly toxic and potentially fatal standard Aids drugs.

I think it’s clear that ICC was founded with good intentions, to assist abandoned, ill and suffering infants. But I also think that a shocking and inexcusable ethical line was crossed when the children began to be used as pharmaceutical test subjects.

I will point out that the vast majority of ICC’s wards were children of crack addicts, themselves born chemically-addicted and profoundly debilitated, according to the childcare workers, nursing staff and children from ICC that I interviewed Here ].

Further, I think, the relabeling of these children as “HIV positive” arises from the non-standardized, highly-flexible nature of HIV testing. Here is my summary of the limitations of the tests, Here is an extensive catalog of citations from the medical literature on the subject.

Beneath the ICC page is a list of drug trials1 in which ICC is listed as a participant/recruiting center. ICC was listed on the NIH trial lists through early 2005, when I was writing this piece for the NY Press.

Bold emphasis added

ICC Webpage

ICC Frontpage (2004) | ICC Page 2 (2004)


Residential transitional care with 24-hour nursing (i.e. “enhanced care”) for chronically-ill HIV infected children who do not need hospitalization but require “round-the-clock” medical and nursing care in a nurturing and home-like setting.

Respite care for medically-complex children whose natural or foster parents are temporarily unable to provide care.

Outpatient diagnostic and medical care for HIV-infected children.

Access to clinical trials of new medications to treat HIV-infected children, under the sponsorship of the National Institute of Allergy and Infectious Diseases.

Training and education for pediatricians-in-training, students of medicine, nursing, social work and law, parents and foster parents.

HIV support groups for parents and older children.

Services/Events – Incarnation Children Center


Stephen Nicholas, M.D., Director

The Department of Pediatrics has played a significant role in the creation and support of Incarnation Children’s Center (ICC), New York City’s only residence for HIV-infected children. Located on Audubon Avenue at 172nd Street in a 4-story red brick former convent, ICC’s residential and outpatient programs have provided care for over 600 HIV-positive children since opening its doors in 1989.

In the mid-1980’s, children with HIV infection and AIDS were often homeless and foster parents were in very short supply. As a result, hundreds of AIDS boarder babies languished for months to years on hospital wards because they had nowhere else to live.

In 1987, Dr. John Nicholson, Professor and Attending of Pediatrics, after finishing a month as ward attending at Harlem Hospital, which had the greatest number of AIDS boarder babies in the city, had an idea to use Incarnation Convent, which was empty, as a home for AIDS babies.

At his prompting, a collaborative group formed: Monsignor Thomas Leonard, then a rector of Incarnation Church; Sister Una McCormack, executive director of Catholic Home Bureau, a foster care and adoption agency of the Archdiocese of New York; Dr. Michael Katz, then chairman of the Department of Pediatrics; Dr. Margaret C. Heagarty, Director of Pediatrics at Harlem Hospital; Jack Rudin of the Samuel and May Rudin Foundation; Brooke Trent, then Deputy Commissioner of the Child Welfare Administration.

This collaborative group envisioned a sanctuary of love, a home-like nurturing residence where HIV-positive children would receive the best possible nursing and medical care while awaiting placement into foster homes.

Dr. Stephen Nicholas was recruited to become the founding medical director. With his assistance and together with cofounders Sister Bridget Kiniry, M.Ed., Sr. Constance Gaynor, M.S.W., and Pamela Clark, R.N., M.P.H., the program was created.

During its first two years, ICC became the Ellis Island for homeless children with AIDS. One hundred and sixty children were admitted to ICC from all five city boroughs. During this period, ICC worked with the Child Welfare Administration and a large number of foster care agencies to encourage foster parents to accept HIV-positive children. As a result, foster parent recruitment increased at an astonishing rate.

After three years, a surplus of foster parents existed for all but the sickest children. New York City’s AIDS boarder baby crisis had ended. ICC had played a pivotal role in this success story. Having accomplished its goal, ICC would have happily closed its doors had it not been for an unexpected discovery.

Pediatric AIDS was first recognized in 1982-83. Early in the epidemic, HIV disease of childhood was considered to be down-hill course leading to death. But in the late 1980’s, before AZT was available, many very ill children admitted to ICC got dramatically better with proper nurturing and high-quality medical and nursing care.

As the importance of convalescent care became clear, many of the sickest HIV-infected children in the city began to be referred to ICC for temporary care.

In 1992, an outpatient clinic for HIV-positive children was established; the same year, with funding from the National Institute of Allergy and Infectious Diseases, the clinic became a sub unit of the Columbia University Pediatric AIDS Clinical Trials Unit, directed by Dr. Anne Gershon, Professor of Pediatrics.

In addition, ICC from its earliest days has worked in close collaboration with the Harlem Hospital Pediatric AIDS Program, directed by Dr. Elaine Abrahms, Associate Professor of Clinical Pediatrics.

Today ICC is an internationally-recognized model of community-based care for children with HIV/AIDS. It’s 1996-97 operating budget is $2.0 million for the residential program and $*756,899 for the clinic program ($286,087 of which is for clinical trials*). A staff of 70 provide a full array of medical, nursing, child care, social, nutritional and developmental services.

Approximately 70 volunteers supplement staff activities. The Friends of Incarnation Children’s Center, a newly-organized non-profit organization for publicity and fund-raising, raised $334,818 in 1996, of which $100,000 was donated by The May and Samuel Rudin Family Foundation for the support of Columbia University medical staff salaries.

ICC medical personnel include three pediatricians, two research nurses, two-field nurses, one senior clerk and one part-time psychologist.

During 1996, ICC’s average residential census was 88.6%, with 42 children admitted for an average length of stay of 82 days.

During clinic sessions each week, 1438 evaluations were given in the past year to 133 HIV-positive children, 118 children were referred for HIV testing. Under the direction of Dr. Nicholas, 34 children are currently participating in 7 clinical trials, including

[_Note: Zidovudine is also known as AZT. Studies on AZT_ ]

  • ACTG 219 (Pediatric Late Protocol);
  • ACTG 240 (zidovudine vs. D4T);
  • ACTG 245 (comparison of didanosine, zidovudine and nevirapine in children/adolescents with advanced HIV diseases);
  • ACTG 254 (atovaquone/azithromycin vs. trimethoprim/sulfamethoxazole to prevent serious bacterial infections);
  • ACTG 300 (zidovudine/3TC vs. didanosine/zidovudine/didanosine);
  • ACTG 327 (a continuation of ACTG 240),
  • and a Roche-sponsored trial of DDC monotherapy.

ACTG 338 (zidovudine/3TC vs. D4T/ritonavir vs. zidovudine/3TC/ritonavir), the first phase II pediatric trial of a protease inhibitor, will start in early 1997. The ICC clinical trials subunit was awarded funding from NIAID for an additional three years (1197-2000).

Dr. Nicholas was promoted in 1996 to Associate Professor of Clinical Pediatrics and Associate Attending. He was listed among The Best Doctors in New York in New York Magazine, and in the 1996-97 edition of The Best Doctors in America.

[end document]

1 ICC’s Drug Trials

NIH/Pharma-Sponsored Drug Studies at ICC

Download as Zip File – ICC NIH Clinical Trials

The following is a list of studies in which ICC is listed as a participant/recruitment center. This is not the end of the list, however, because children at ICC are treated at the major hospitals in the New York metropolitan area, and can be enrolled in studies there as well.

ICC functions as a magnet structure for children in the major metropolitan area. Patients from the five burroughs, and more than a half dozen hosptials are taken into ICC, most often, I was told by ICC’s medical director, Dr. Katherine Painter, for issues relating to “adherence.” That is, refusal to take the drugs.

Studies funded by Pharmaceutical Companies:

  • Glaxo Wellcome (now GSK)
  • Bristol-Myer Squibb
  • Genentech
  • Biocine
  • Pfizer
  • Protein Sciences Corporation,
  • And the NIH, NIAID, NICHD and other government agencies – that’s tax dollars, mine and yours.

Terms used in the studies:

  • “Recruiting” = ongoing studies that are taking new participants.
  • “No longer recruiting” = Ongoing studies that are not taking new participants.
  • “Completed” = a study that is over.
  • “Terminated” = a study that was ended early.
  • Lipodystrophy – bodily deformation from Aids drugs, especially protease inhibitors

Also Note: Studies with:

  • HIV-negative (“seronegativity”)
  • “Presumed HIV-infected Infants”
  • Healthy (“asymptomatic”) 1 month olds
  • With “7 drugs, some at higher than usual doses” in “4 to 22 year olds.”
  • Also, the many vaccine studies in these children.


Search results for ( incarnation AND hiv ) [ALL-FIELDS] are shown below.

Include trials that are no longer recruiting patients.

36 studies were found.

[Zip File]

1. No longer recruiting A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

Conditions: HIV Infections; HIV Seronegativity

2. Completed A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection

Condition: HIV Infections

3. No longer recruiting A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group

Conditions: HIV Infections; Measles

4. No longer recruiting The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

Conditions: HIV Infections; HIV Wasting Syndrome; Lipodystrophy

5. Completed Comparison of New Anti-HIV Drug Combinations in HIV-Infected Children Who Have Taken Anti-HIV Drugs

Condition: HIV Infections

6. Completed A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV

Condition: HIV Infections

7. Completed A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

Condition: HIV Infections

8. No longer recruiting Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children With Weakened Immune Systems

Condition: HIV Infections

9. No longer recruiting A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children

Condition: HIV Infections

10. No longer recruiting A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children

Condition: HIV Infections

11. Completed Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens

Condition: HIV Infections

12. Recruiting The Effects of Anti-HIV Therapy on the Immune Systems of Children and Young Adults Infected With HIV

Condition: HIV Infections

13. No longer recruiting Long-Term Effects of HIV Exposure and Infection in Children

Conditions: HIV Infections; HIV Seronegativity

14. Completed A Study of Dideoxyinosine (ddI) in HIV-Infected Children Who Have Not Had Success With Zidovudine or Who Cannot Take Zidovudine

Condition: HIV Infections

15. No longer recruiting A Phase I Trial to Evaluate Didanosine (ddI) in HIV-Infected Pregnant Women

Conditions: HIV Infections; Pregnancy

16. Completed A Randomized Comparative Trial of Zidovudine (AZT) Versus 2’,3’-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children

Condition: HIV Infections

17. Terminated “The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children

Conditions: Herpes Simplex; HIV Infections; Chickenpox

18. Completed A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2’,3’-Didehydro-3’-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

Condition: HIV Infections

19. No longer recruiting A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment

Condition: HIV Infections

20. No longer recruiting A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants

Conditions: HIV Infections; Pneumococcal Infections

21. No longer recruiting A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

Conditions: Bacterial Infections; Pneumonia, Pneumocystis Carinii; HIV Infections

22. Completed Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

Conditions: HIV Infections; Pregnancy

23. Completed Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

24. Completed A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

Condition: HIV Infections

25. Completed A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.

Condition: HIV Infections

26. No longer recruiting A Study to Test the Safety of Recombinant Interleukin-2 (rIL-2) in HIV-Infected Children

Condition: HIV Infections

27. No longer recruiting Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

Condition: HIV Infections

28. No longer recruiting A Study to Compare Two Different Anti-HIV Drug Regimens

Condition: HIV Infections

29. No longer recruiting A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children

Condition: HIV Infections

30. No longer recruiting A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses

Condition: HIV Infections

31. No longer recruiting A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

Conditions: Cytomegalovirus Infections; HIV Infections

32. No longer recruiting Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

Condition: HIV Infections

33. No longer recruiting Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox

Conditions: HIV Infections; Chickenpox

34. Completed Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems

Condition: HIV Infections

35. Completed A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

Condition: HIV Infections

36. Completed Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children

Condition: HIV Infections

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National Institutes of Health, Department of Health & Human Services

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