HIV Infections Clinical Trial
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
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.
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 They have blood withdrawn to study the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.
;
Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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