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Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000876
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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
HIV Infections Drug: CD4-IgG2 Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of CD4-IgG2 in HIV-Infected Children

Resource links provided by NLM:


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

Estimated Enrollment: 12
Study Completion Date: November 2006
Detailed Description:

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.]

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Children may be eligible for this study if they:

  • Are HIV-positive.
  • Are 2-12 years old and have consent of parent or legal guardian.
  • Have HIV levels of 10,000 copies/ml or more on at least 2 occasions and 30 days apart (Part 2 only).
  • Have been on stable, unchanged anti-HIV therapy for 3 months before study entry.

Exclusion Criteria

Children will not be eligible for this study if they:

  • Have an active opportunistic (HIV-related) infection.
  • Are pregnant.
  • Are taking certain medications.
  • Have received any vaccinations within 30 days prior to study entry.
  • Have a heart problem that would affect their ability to take part in the study. (This study has been changed. The original version didn't mention heart problems.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000876


Locations
United States, California
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States, 900276016
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90090-1752
Children's Hosp. of Orange County
Orange, California, United States, 92868
UCSF Pediatric AIDS CRS
San Francisco, California, United States, 941430105
United States, District of Columbia
Children's National Med. Ctr. Washington DC NICHD CRS
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
United States, Texas
Texas Children's Hosp. CRS
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Chair: William Shearer
Study Chair: Stuart Starr
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000876     History of Changes
Other Study ID Numbers: PACTG 351
10699 ( Registry Identifier: DAIDS ES Registry Number )
ACTG 351
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: May 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Antiviral Agents
CD4-IgG(2)
PRO 542

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulin G
CD4 Immunoadhesins
Immunologic Factors
Physiological Effects of Drugs