A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4-Immunoglobulin G (rCD4-IgG) Administered by Intravenous Bolus Injection in Combination With Oral Zidovudine in Patients With AIDS and AIDS-Related Complex

NCT00000976 | Completed Phase 1

• 2 other identifiers: ACTG 134D0156g
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

To determine the safety profile of recombinant human CD4-immunoglobulin G (CD4-IgG) and zidovudine (AZT) combination therapy in patients with AIDS or AIDS-related complex (ARC); to assess pharmacokinetic (blood level) properties of CD4-IgG in combination with AZT; and to obtain preliminary indication of the antiviral and immunologic effects of CD4-IgG in combination with AZT in patients with AIDS and ARC. Treatment of AIDS has been directed toward the underlying retroviral infection as well as toward specific opportunistic infections and malignancies that are associated with the syndrome. The most extensively studied drugs are reverse transcriptase inhibitors such as AZT and other nucleoside analogs, including didanosine (ddI) and dideoxycytidine (ddC). The most extensive clinical experience has been achieved with AZT. These clinical trials indicated a decreased incidence of opportunistic infection and increased survival in patients with AIDS. However, AZT treatment is associated with dose-limiting toxicities. Additionally, identification of resistance to AZT has increased the need to test the effectiveness of AZT in combination with other drugs. CD4-IgG is capable of binding to HIV envelope protein (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in patients with HIV infection may be derived from CD4-IgG.

Conditions

HIV Infections

Keywords

Recombinant Proteins; Injections, Intravenous; IgG; Drug Evaluation; Administration, Oral; Acquired Immunodeficiency Syndrome; Antigens, CD4; Zidovudine; Carrier Proteins

Interventions

CD4-IgG DRUG

Zidovudine DRUG

Eligibility Criteria

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

You may qualify if:

• Concurrent Medication:
• Allowed:
• Topical acyclovir.
• Patients must have the following:
• HIV seropositivity.
• Life expectancy of at least 3 months.
• No white or red blood cell casts in urine.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Serious active opportunistic infection or malignancies other than Kaposi's sarcoma.
• Kaposi's sarcoma requiring therapy, tumor-associated edema, or visceral disease.
• Concurrent Medication:
• Excluded:
• Intravenous acyclovir for Herpes.
• Interferon.
• Systemic corticosteroids.
• Nonsteroidal anti-inflammatory agents.
• Intravenous acyclovir.
• Other known immunomodulatory agents.
• Dideoxycytosine (ddC), didanosine (ddI).
• Other nucleoside analogs not specifically allowed.
• Other experimental therapy.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Genentech, Inc.: collaborator

Study Sites (3)

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Univ of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• Meng TC, Fischl MA, Cheeseman SH, Spector SA, Resnick L, Boota A, Petrakis T, Wright B, Richman DD. Combination therapy with recombinant human soluble CD4-immunoglobulin G and zidovudine in patients with HIV infection: a phase I study. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Feb 1;8(2):152-60.

  PMID: 7834398 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

CD4 Immunoadhesins; Zidovudine

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)

Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins; Antigens, Surface; Antigens; Biological Factors; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• D Richman

  STUDY CHAIR

• M Fischl

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: August 6, 2008

Record last verified: 1994-12

Locations

US (3)