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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000876 |
CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4 cells (cells of the immune system that fight infection). The purpose of this study is to see if giving CD4-IgG2 to HIV-infected children is safe and effective.
HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help the virus invade the body. CD4 cells are killed or disabled during this process of HIV replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts become very low, the body is unable to defend itself, and HIV infection develops into AIDS. The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children.
Condition | Intervention | Phase |
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HIV Infections |
Drug: CD4-IgG2 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | Phase I/II Trial of CD4-IgG2 in HIV-Infected Children |
Estimated Enrollment: | 24 |
Since CD4 is the high-affinity receptor for HIV-1, molecules such as CD4-IgG2, which incorporate the gp120 binding region of CD4, have the potential to bind and neutralize all strains of the virus. [AS PER AMENDMENT 4/25/00: Study results have demonstrated that the product is safe in children, well tolerated, and may have antiviral properties. With these encouraging results in hand, an extra cohort has been added using twice the dose of rCD4-IgG2 as in Cohort I.]
The study is conducted in two parts. In Part 1 patients receive a single dose of CD4-IgG2 intravenously at 1 of 4 dose levels. A minimum of 3 patients are treated at a given dose level. If none of these 3 patients experience Grade 3 or 4 toxicity, patients are escalated to the next dose level. If any of these 3 patients have life-threatening toxicities or if more than 1 of these 3 patients experience non-life-threatening Grade 3 or 4 toxicities, escalation stops and the prior dose (if any) is considered the maximum tolerated dose (MTD). If 1 of these 3 patients experiences non-life-threatening Grade 3 or 4 toxicities, 3 additional patients are treated at this dose level. If 1 or more of these 3 additional patients has Grade 3 or 4 toxicity, escalation stops. If none of these 3 additional patients has Grade 3 or 4 toxicity, patients are escalated to the next dose level.
Part 2 provides additional data on the safety, toxicity and pharmacokinetics of CD4-IgG2 when given in multiple doses. Patients receive the highest safe dose (MTD) as established in Part 1. Treatment is given intravenously once weekly at Weeks 0, 1, 2, and 3. If insufficient activity is seen at this dose level, 6 additional patients will be enrolled at a higher dose level. Patients who participate in Part 1 may enroll in Part 2 provided they are followed for at least 3 months and meet inclusion criteria for Part 2. If any patient experiences a life-threatening condition due to CD4-IgG2, the study will stop. [AS PER AMENDMENT 4/25/00: Cohort II receives twice the dose of Cohort I intravenously once weekly at Weeks 0, 1, 2 and 3. Pharmacokinetic samples are obtained at pre-dose and 1 hour after the doses are administered at Weeks 0, 1, and 2; and pre-dose, 1 hour, 24 hours, and Days 3, 7, and 14 after the dose are administered at Week 3. An overnight stay in the hospital is recommended for the first 24 hours. At Weeks 0, 1, 2, and 3, virology testing including HIV-1 RNA is performed with each infusion of CD4-IgG. Follow-up monitoring of patients is done once a month for 4 months for patients in Cohort II.]
Ages Eligible for Study: | 2 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Children may be eligible for this study if they:
Exclusion Criteria
Children will not be eligible for this study if they:
United States, California | |
UCSF / Moffitt Hosp - Pediatric | |
San Francisco, California, United States, 941430105 | |
Children's Hosp of Oakland | |
Oakland, California, United States, 946091809 | |
Children's Hosp of Los Angeles/UCLA Med Ctr | |
Los Angeles, California, United States, 900276016 | |
UCLA Medical Center (Pediatric) | |
Los Angeles, California, United States, 90090-1752 | |
Children's Hosp of Orange County | |
Orange, California, United States, 92868 | |
Long Beach Memorial (Pediatric) | |
Long Beach, California, United States, 90801 | |
United States, District of Columbia | |
Children's National Med Ctr | |
Washington, District of Columbia, United States, 20010-2970 | |
United States, Florida | |
Univ of Florida Health Science Ctr / Pediatrics | |
Jacksonville, Florida, United States, 32209 | |
United States, Michigan | |
Children's Hosp of Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, New York | |
Schneider Children's Hosp | |
New Hyde Park, New York, United States, 11040 | |
United States, Pennsylvania | |
Children's Hosp of Philadelphia | |
Philadelphia, Pennsylvania, United States, 191044318 | |
United States, Texas | |
Texas Children's Hosp / Baylor Univ | |
Houston, Texas, United States, 77030 |
Study Chair: | William Shearer | |
Study Chair: | Stuart Starr |
Study ID Numbers: | ACTG 351, PACTG 351 |
Study First Received: | November 2, 1999 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00000876 |
Health Authority: | United States: Food and Drug Administration |
Antiviral Agents CD4-IgG(2) PRO 542 |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome CD4 Immunoadhesins Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Lentivirus Infections Infection Pharmacologic Actions |