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

June 23, 2005 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 They have blood withdrawn to study the response to rCD4 and measure the activity of rCD4 in the body.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.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Northern California Pediatric AIDS Treatment Ctr / UCSF
      • Stanford, California, United States, 943054149
        • Stanford Univ School of Medicine / Pediatrics
    • Illinois
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's Memorial Hosp
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Med Ctr
    • New Jersey
      • Newark, New Jersey, United States, 071072198
        • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
    • North Carolina
      • Durham, North Carolina, United States, 277103499
        • Duke Univ Med Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylactic medication for patients with previous documented episodes of Pneumocystis carinii pneumonia (PCP).
  • Concomitant zidovudine (AZT) or intravenous gamma globulin (IVIG) during maintenance therapy phase of the study.

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:

  • Asymptomatic.
  • Mildly symptomatic but not eligible for and/or decline ACTG protocol 052.
  • Markedly symptomatic but not eligible for and/or decline ACTG protocol 051 or cannot tolerate zidovudine (AZT) therapy.

All patients must have:

  • A life expectancy of at least 3 months.
  • A legally-qualified guardian with the ability to sign a written informed consent form, which must be obtained prior to treatment. A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Zidovudine (AZT).
  • Intravenous gamma globulin (IVIG).
  • Pentamidine.
  • Trimethoprim / sulfamethoxazole (TMP/SMX).
  • Corticosteroids.
  • Nonsteroidal anti-inflammatory agents (NSAIDS).
  • Other known immunomodulatory agents.
  • All other experimental therapies.

Patients will be excluded from the study for the following reasons:

  • Serious active opportunistic infection or malignancies prior to study entry.
  • Defined organ insufficiencies.

Prior Medication:

Excluded within 3 weeks of study entry:

  • Zidovudine (AZT).
  • Intravenous gamma globulin.
  • Cancer chemotherapy.
  • Immunomodulatory agents.
  • Other experimental therapy.

Patients may not have any of the following diseases or symptoms:

  • Serious active opportunistic infection or malignancies prior to study entry.
  • Cardiopathy.
  • Two or more episodes of prior Pneumocystis carinii pneumonia (PCP).
  • Hematologic insufficiency defined as granulocytes = or < 1000 cells/mm3; platelets = or < 100000 cells/mm3; hemoglobin = or < 8 g/dl.
  • Renal insufficiency defined as creatinine > 2 mg/dl; = or > 5 white blood cells or red blood cells/hpf or = or > 2+ proteinuria in urine.
  • Hepatic insufficiency defined as bilirubin = or > 3 x upper limit of normal; SGOT = or > 10 upper limit of normal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Genentech, Inc.

Investigators

  • Study Chair: P Weintrub

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Weintrub P, Yogev R, Conner E, Wilfert K, Mordenti J, Ammann AJ. Safety and pharmacokinetics of recombinant CD4 in children with HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB23)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 1996

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 101
  • CO102G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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