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| 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 |
| Estimated Enrollment: | 40 |
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 They have blood withdrawn to study the response to rCD4 and measure the activity of rCD4 in the body.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:
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
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:
All patients must have:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients will be excluded from the study for the following reasons:
Prior Medication:
Excluded within 3 weeks of study entry:
Patients may not have any of the following diseases or symptoms:
Contacts and 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 | |
| Study Chair: | P Weintrub |
More Information
| 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 |
|
Recombinant Proteins Acquired Immunodeficiency Syndrome Antigens, CD4 Antiviral Agents |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Antiviral Agents Retroviridae Infections Immunologic Deficiency Syndromes |
|
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 |