A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)

NCT00000659 | Terminated Phase 2

• 2 other identifiers: ACTG 133C89-013-P
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT. Parts 1B and 2: To test for additive or synergistic activity between rsCD4 and AZT as judged by falls in HIV-1 p24 antigen levels; and to evaluate the safety of rsCD4 and AZT in patients with AIDS and advanced ARC. AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT. The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4 (rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT.

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; Antigens, CD4; AIDS-Related Complex; Zidovudine

Interventions

CD4 Antigens DRUG

Zidovudine 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 as chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).
• Trimethoprim / sulfamethoxazole (TMP / SMX) for patients who are clinically and hematologically stable on TMP / SMX PCP prophylaxis.
• Patients must have the following:
• Diagnosis of AIDS or advanced AIDS related complex (ARC).
• CD4 cell count \< 300 cells/mm3.
• Ability to understand and sign the consent form.
• Risk Behavior:
• Allowed:
• History of drug abuse with current abstinence or enrollment in a methadone treatment program.

You may not qualify if:

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Malignancies other than Kaposi's sarcoma.
• AIDS dementia which, in the opinion of the investigator, precludes patients from giving fully informed consent or from complying fully with the requirements of this protocol.
• Active infection with an opportunistic pathogen requiring ongoing therapy.
• Preexisting antibodies to rCD4.
• Concurrent Medication:
• Excluded:
• Investigational drugs.
• Antiretroviral agents such as dextran sulfate or AL721.
• Cytotoxic chemotherapy.
• Concurrent Treatment:
• Excluded:
• Radiation therapy.
• Patients with the following are excluded:

Sponsors & Collaborators

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

Study Sites (2)

Tulane Univ School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

CD4 Antigens; 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)

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; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• RT Schooley

  STUDY CHAIR

• DD Ho

  STUDY CHAIR

• TC Merigan

  STUDY CHAIR

• L Laubenstein

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: July 1, 1990
• Last Updated: March 14, 2011

Record last verified: 1990-07

Locations

US (2)