Pediatric HIV/AIDS Research In Northeast Florida
L. Michelle Eagle, P.A.-C, CCRC
L. Michelle Eagle, P.A.-C, CCRC is the Associate Director of Research,
Division of
Infectious Disease and Immunology at the University of Florida Health Science
Center / Jacksonville
and the Rainbow Center for Women, Adolescents, Children and Families.
The Rainbow Center for Women, Adolescents, Children and Families is located at Shands
Jacksonville, an urban campus of the University of Florida. The Rainbow Center is the only
Center in Northeast Florida for the care of HIV positive children and their families. The
children and adults infected with HIV have access to cutting edge research through the
Rainbow Center. Patients have been enrolled in over 30 different HIV related trials in the
past five years. The Rainbow Center is a unit for the National Institute of Health's (NIH)
AIDS Clinical Trials Group (ACTG). As such, our patients have access to federally funded
NIH trials. In addition, we also participate in pharmaceutical industry sponsored studies.
Our research has varied from vaccine trials to primary therapy, from perinatal
interventions to nutrition and observational studies. This allows us to offer a wide range
of programs for our patients. We have a large multidisciplinary staff, which is dedicated
to providing quality healthcare along with access to research opportunities that are not
available at other sites locally. At some level, our entire staff is involved in the
research projects. We have participated in multiple studies that have a direct impact on
the management of HIV infected and exposed infants and children. Our adult trials focus on
women (both pregnant and non-pregnant), although some men have also participated in
trials. The Rainbow Center's research activities have included many firsts for Florida and
Jacksonville including the first HIV research trial in North Florida, first perinatal
intervention in North Florida, first vaccine trial in Florida, first use of
immunemodulator in Jacksonville, and very soon, the first gene therapy research protocol
in Florida.
Many staff members of the Rainbow Center have a leadership role in the Pediatric ACTG
staff and serve on many important committees of the PACTG and have key roles in
development and conducting of national research trials under the auspices of NIH. Our
center was the highest rated application during the recent recompetition for NIH grant to
become a research site. We participate in national meetings and many of our staff is
involved in committees which promote HIV/AIDS research. Our committee work with the PACTG
includes work with the scientific agenda, social and adherence issues, and several members
of our staff are on PACTG protocol teams. This committee work gives our personnel insight
into the study procedures and direct input into the direction of Pediatric HIV research at
a national level.
The results of many studies in which our site has participated have been published in
major peer reviewed journals, including the New England Journal of Medicine. The
impact of many of the pivotal studies can be seen in the current standard of care for
children and pregnant women with HIV. The document, Guidelines for the Use of
Antiretroviral Agents in Pediatric HIV Infection, published March 1, 1999, is the
guide for the standard of care in Pediatric HIV management. The guide used results from
many PACTG trials to establish the standards of care, with many Rainbow Center patients
contributing significantly to the results.
The Rainbow Center has participated in Phase I, II, and III trials. Phase I involves a
small number of healthy volunteers and is the initial introduction of an investigational
agent into humans. The metabolism, pharmacologic parameters, and side effect information
with respect to dose escalation are the main focus of Phase I research. This phase of
research is especially challenging due to the intense pharmacokinetic information that is
required to be gathered. Patients are usually required to have multiple all day visits and
some require overnight hospital stays. Results of Phase I studies must be obtained prior
to designing and implementing a Phase II study. Phase II studies are conducted to evaluate
the effectiveness of an investigational drug in patients with a particular disease. It is
also designed to obtain data on the short-term side effects and risks. The number of
patients studied is usually in the few hundreds. Phase III studies involve hundreds of
thousands of patients. The goals is to gather information regarding the risk-benefit
relationship through additional assessment of the effectiveness and safety. Phase III
studies are usually sentinel registration trials used for FDA approval.1
We are among a few NIH and pharmaceutical industry sites selected to participate in
Phase I studies and have done so with great success. This phase of research, while at
times has little direct benefit to the participant, has great implications in the use and
dosage of medications. This is especially true for infants and children when little
information is known about the metabolism of many of the antiviral medications. These
drugs are essential for controlling the replication of HIV in infants and children, but
without the pharmacokinetic information on this population it is impossible to know what
dosages to use and what the possible side effects may be. In HIV research, the trials may
be accelerated and sometimes phases of the trials are combined. This is to increase the
number of patients eligible by allowing patients who are in the phase I trial to be
continued into the phase II trial once the data is established.
We are very fortunate to be able to offer our patients participation in a variety of
research opportunities. Our staff is experienced and competent in all aspects of research
and patient care. We are greatly indebted to our patients for their participation in the
research trials. Printed below is a listing of trials. Do not hesitate to contact our
office with any specific questions.
REFERENCE
1. Baron Polanksy Associates, Inc. Phases of an Investigation. Good Clinical Practices.
Current HIV Related Studies At The
Rainbow Center |
| Pediatric: Pediatric
Late Outcomes Protocol.
A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose
Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multi-Center Trial of
the Pediatric AIDS Clinical Trials Groups.
A Randomized, Double Blind, Controlled Study of an Increased Caloric Density
Infant Formula and Its Effect on Growth and Nutritional Status in HIV Infected Infants.
A Randomized, Phase II/III, Double-Blind, Placebo Controlled, Two-Armed Study of
Micronized-Atovaquone and Azithromycin (AT/AZ) as Compared to
Trimethoprim-Sulfamethoxazole (TMP/SMX) in the Prevention of Serious Bacterial Infections
when used in Children Ages 2-19 years with HIV Infection.
A Double Blind Placebo Controlled Trial of the Safety and Immunogenicity of a
Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants.
A Phase I/II Trial of Recombinant Interleukin-2 in Symptomatic Human
Immunodeficiency Virus-Infected Children.
Phase I Study of Safety, Tolerance, and Pharmacokinetics of 1592U89 with
Standard Zidovudine (ZDV) Therapy in Neonates Born to HIV-1 Infected Women.
A Phase I/II Study to Evaluate the Safety and Immunogenicity of ALVAC HIV
Vaccine in Children born to HIV-Infected Mothers.
A Phase II Rolling Arm Master Protocol (PRAM) of Novel Antiretroviral Therapy in
Stable, Experienced, HIV-Infected Children PRAM-1: ZDV+3TC™ vs. d4T+Ritonavir vs.
ZDV+3TC™+ Ritonavir.
Phase I/II Trial of CD4-IgG2 in HIV-Infected Children.
Establishment and Maintenance of Long-Term Undetectable Plasma HIV-1 RNA:
Correlation with Immunologic Reconstitution and Viral Dynamics.
A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral
Nelfinavir (Viracept®) Co-Administered with Zidovudine (ZDV) and Lamivudine (3TC™)
in HIV Infected Pregnant Women and Their Infants.
A Phase I/II, Open-Label, AUC-Controlled Study to Determine the
Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of DMP 266 in Combination
with Nelfinavir in Children. |
Pediatric (cont.) Mononuclear
Cell Phenotyping in Normal Children.
A Phase III, Open Label Trial to Evaluate the Safety, Antiviral Efficacy and
Pharmacokinetics of 141W94 Plus Current Therapy in HIV-1 Infected Children.
An Open-Label Study of MKC-442 in Combination with Nucleoside Reverse
Transcriptase Inhibitors in HIV-1 Infected Pediatric Patients to Evaluate its
Pharmacokinetics, Preliminary Safety and Antiviral Efficacy.
A Placebo Controlled Phase III Evaluation of Suppressive Therapy with Oral
Acyclovir Suspension Following Neonatal Herpes Simplex Virus Infections Limited to the
Skin, Eye, and Mouth.
Perinatal:
A Randomized Phase III Trial of Oral Isotretinoin vs. Observation for Low Grade
Cervical Dysplasia in HIV-Infected Women.
A Phase III Randomized, Blinded Study of Nevirapine for the Prevention of
Maternal-fetal Transmission in Pregnant HIV-Infected Women.
A Phase I/II, Open Label Study to Evaluate the Safety, Tolerance and
Pharmacokinetics of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV Infected
Pregnant Women and Their Infants.
A Phase I Trial of the Safety, Tolerance and Pharmacokinetics of Oral Indinavir
Co-Administered with 3TC™ and ZDV in HIV-1 Pregnant Women during Gestation and
Postpartum, and in their Infants Post Maternal Dosing.
A Medical Chart Abstraction of HIV-Infected Pregnant Women and Their Infants
Receiving Care or Consultation at Study Sites.
Adult:
An Open-Label Study of MKC-442 in at Least Triple Drug Combination in Patients
Previously Treated with Nucleoside Reverse Transcriptase and Protease Inhibitors and Who
are Naive to Non-Nucleoside Reverse Transcriptase Inhibitors.
The Effect of a Weekly Dosing Regimen of PROCRIT® (Epoetin alfa) on the Quality
of Life in the Treatment of Anemia in HIV-Infected Patients on Antiretroviral Therapy.
A Phase I/II Study in HIV-1 Infected Patients Infused with CD34+Thy1+
hematopoietic Stem Cells (HSC) from G-CSF Mobilized Peripheral Blood Retrovirally
Transduced with RevM10 or RevM10/Antisense pol 1. |
December, 1999/ Jacksonville Medicine
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