An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive

NCT00000721 | Completed Phase 1

• 3 other identifiers: ACTG 06611040066 Extension
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of BG8962 when it is administered by intramuscular and subcutaneous routes; and to look for dose related antiviral activity determined by quantitation of infectious HIV peripheral blood leukocytes (PBLs) and plasma, and by monitoring the blood levels of viral p24 antigen (when present), CD4+ T-cells, and Beta-2- microglobulin. Recombinant soluble CD4 protein (rCD4) is a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4 binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction. Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date, Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to distinguish between these two products, a change in nomenclature has been made. In this protocol, whenever the original sequence CD4 molecule is referred to, it is called recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed generically, it is referred to as rsCD4.

Conditions

HIV Infections

Keywords

Recombinant Proteins; Infusions, Intravenous; Injections, Intramuscular; Injections, Intravenous; Injections, Subcutaneous; Dose-Response Relationship, Drug; Drug Evaluation; Acquired Immunodeficiency Syndrome; Antigens, CD4; AIDS-Related Complex

Interventions

CD4 Antigens DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Nystatin or clotrimazole for suppression of oral thrush.
• Aerosolized pentamidine for Pneumocystis prophylaxis in Group A patients.
• Trimethoprim / sulfamethoxazole for Pneumocystis prophylaxis in patients who are hematologically stable on trimethoprim / sulfamethoxazole.
• Patients must have:
• Group A: AIDS and symptoms defined in disease status.
• Group B: AIDS related complex (ARC) and symptoms defined in disease status.

You may not qualify if:

• Co-existing Condition:
• Patients with the following disease or conditions are excluded:
• Malignancies other than Kaposi's sarcoma.
• AIDS dementia.
• Opportunistic infections requiring ongoing therapy except oral thrush suppression with nystatin or clotrimazole or Pneumocystis prophylaxis in Group A patients.
• Significant organ system dysfunction including:
• Granulocytopenia with a granulocyte count \< 1000 cells/mm3.
• Thrombocytopenia - \< 75000 platelets/mm3.
• Anemia with a hemoglobin \< 9.5 g/dl.
• Renal dysfunction - creatinine \> 2 mg/dl.
• Hepatic dysfunction with enzymes or bilirubin \> 3 x upper limit of normal.
• Patients with the following are excluded:
• Preexisting antibodies to rCD4.
• Malignancies other than Kaposi's sarcoma.
• AIDS-dementia complex.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Biogen: collaborator

Study Sites (1)

Stanford CRS

Palo Alto, California, 943055107, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

CD4 Antigens

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Receptors, Interleukin-16; Receptors, Interleukin; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, HIV; Receptors, Virus; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers

Study Officials

• Schooley RT

  STUDY CHAIR

• Merigan TC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: March 1, 1991
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (1)