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
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.
Visão geral do estudo
Descrição detalhada
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 They have blood withdrawn to study the response to rCD4 and measure the activity of rCD4 in the body.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.
Tipo de estudo
Inscrição
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
-
-
California
-
San Francisco, California, Estados Unidos, 94143
- Northern California Pediatric AIDS Treatment Ctr / UCSF
-
Stanford, California, Estados Unidos, 943054149
- Stanford Univ School of Medicine / Pediatrics
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 606143394
- Chicago Children's Memorial Hosp
-
Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Med Ctr
-
-
New Jersey
-
Newark, New Jersey, Estados Unidos, 071072198
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 277103499
- Duke Univ Med Ctr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Mascaramento: Nenhum (rótulo aberto)
Colaboradores e Investigadores
Colaboradores
Investigadores
- Cadeira de estudo: P Weintrub
Publicações e links úteis
Publicações Gerais
- 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)
Datas de registro do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Infecções por vírus de RNA
- Doenças Virais
- Infecções transmitidas pelo sangue
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Atributos da doença
- Doenças de Vírus Lento
- Infecções por HIV
- Infecções
- Doenças Transmissíveis
- Síndrome da Imunodeficiência Adquirida
Outros números de identificação do estudo
- ACTG 101
- CO102G
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .