A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection - Full Text View

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Genentech
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000984

Purpose

AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: To determine whether the experimental drug recombinant CD4 (rCD4), which is produced through genetic engineering technology, is safe and well-tolerated in children infected with or at risk for HIV infection.

rCD4 may be an effective treatment for HIV infection, based on its ability to block infection of human cells by HIV in laboratory tests. However, the activity of rCD4 still needs to be confirmed in clinical trials. It is hoped that these tests will show that rCD4 is both safe and effective in treating children who are infected with or who are at risk for infection with HIV.

Condition	Intervention	Phase
HIV Infections	Drug: CD4 Antigens	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Pharmacokinetics Study
Official Title:	A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

40

Detailed Description:

rCD4 may be an effective treatment for HIV infection, based on its ability to block infection of human cells by HIV in laboratory tests. However, the activity of rCD4 still needs to be confirmed in clinical trials. It is hoped that these tests will show that rCD4 is both safe and effective in treating children who are infected with or who are at risk for infection with HIV.

Children have preliminary testing and evaluation to determine eligibility and health. The dosage schedule varies with the dose. During the course of the study, children are monitored for safety through physical exams and blood tests. They have blood withdrawn to study the response to rCD4 and measure the activity of rCD4 in the body. Children may receive immunization of DPT (diphtheria, pertussis, tetanus) or DT and a polio vaccine to measure their antibody response. If the rCD4 is beneficial, children may continue treatment. The study is conducted in four parts:

Part A: Children 13 to 18 years old.
Part B: Children 3 months to less than 13 years old.
Part C: Full-term infants over 3 months old.
Part D: Preterm infants less than 3 months old. Parts C and D are not started until parts A and B have been completed.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Prophylactic medication for patients with previous documented episodes of Pneumocystis carinii pneumonia (PCP).
Concomitant zidovudine (AZT) or intravenous gamma globulin (IVIG) during maintenance therapy phase of the study.

AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled.

Original design: Patients must be infected with HIV or at risk for HIV infection. They must be one of the following:

Asymptomatic.
Mildly symptomatic but not eligible for and/or decline ACTG protocol 052.
Markedly symptomatic but not eligible for and/or decline ACTG protocol 051 or cannot tolerate zidovudine (AZT) therapy.

All patients must have:

A life expectancy of at least 3 months.
A legally-qualified guardian with the ability to sign a written informed consent form, which must be obtained prior to treatment. A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.

Exclusion Criteria

Concurrent Medication:

Excluded:

Zidovudine (AZT).
Intravenous gamma globulin (IVIG).
Pentamidine.
Trimethoprim / sulfamethoxazole (TMP/SMX).
Corticosteroids.
Nonsteroidal anti-inflammatory agents (NSAIDS).
Other known immunomodulatory agents.
All other experimental therapies.

Patients will be excluded from the study for the following reasons:

Serious active opportunistic infection or malignancies prior to study entry.
Defined organ insufficiencies.

Prior Medication:

Excluded within 3 weeks of study entry:

Zidovudine (AZT).
Intravenous gamma globulin.
Cancer chemotherapy.
Immunomodulatory agents.
Other experimental therapy.

Patients may not have any of the following diseases or symptoms:

Serious active opportunistic infection or malignancies prior to study entry.
Cardiopathy.
Two or more episodes of prior Pneumocystis carinii pneumonia (PCP).
Hematologic insufficiency defined as granulocytes = or < 1000 cells/mm3; platelets = or < 100000 cells/mm3; hemoglobin = or < 8 g/dl.
Renal insufficiency defined as creatinine > 2 mg/dl; = or > 5 white blood cells or red blood cells/hpf or = or > 2+ proteinuria in urine.
Hepatic insufficiency defined as bilirubin = or > 3 x upper limit of normal; SGOT = or > 10 upper limit of normal.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000984

Locations

United States, California
Stanford Univ School of Medicine / Pediatrics
Stanford, California, United States, 943054149
Northern California Pediatric AIDS Treatment Ctr / UCSF
San Francisco, California, United States, 94143
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Children's Memorial Med Ctr
Chicago, Illinois, United States, 60614
United States, New Jersey
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States, 071072198
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Genentech

Investigators

Study Chair:

P Weintrub

More Information

Publications:

Weintrub P, Yogev R, Conner E, Wilfert K, Mordenti J, Ammann AJ. Safety and pharmacokinetics of recombinant CD4 in children with HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB23)

Study ID Numbers:	ACTG 101, CO102G
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000984 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Recombinant Proteins
Acquired Immunodeficiency Syndrome
Antigens, CD4
Antiviral Agents

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Antiviral Agents
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009