search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CD4-IgG2
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Antiviral Agents, CD4-IgG(2), PRO 542

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Children's Hosp. of Orange County
  • UCSF Pediatric AIDS CRS
  • Children's National Med. Ctr. Washington DC NICHD CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Texas Children's Hosp. CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000876
Brief Title
Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
Official Title
Phase I/II Trial of CD4-IgG2 in HIV-Infected Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

5. Study Description

Brief Summary
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.
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.]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Antiviral Agents, CD4-IgG(2), PRO 542

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CD4-IgG2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Shearer
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stuart Starr
Official's Role
Study Chair
Facility Information:
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276016
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90090-1752
Country
United States
Facility Name
Children's Hosp. of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Children's National Med. Ctr. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11069253
Citation
Shearer WT, Israel RJ, Starr S, Fletcher CV, Wara D, Rathore M, Church J, DeVille J, Fenton T, Graham B, Samson P, Staprans S, McNamara J, Moye J, Maddon PJ, Olson WC. Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team. J Infect Dis. 2000 Dec;182(6):1774-9. doi: 10.1086/317622. Epub 2000 Oct 27.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs