A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001006
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

To determine the toxic effects of AS-101 at various doses in patients with AIDS or AIDS related complex. Also to determine the effect of various doses of AS-101 on immune functions and the occurrence of infections in these patients. AIDS is a viral disease that is characterized by a loss of some immune function and the development of frequent, eventually fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs. AS-101 is a synthetic organic compound containing the metal tellurium that is being tested because in laboratory studies it improved immune functions.


Condition Intervention Phase
HIV Infections
Drug: AS-101
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase One Study of AS-101 in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 30
Study Completion Date: March 1993
Detailed Description:

AIDS is a viral disease that is characterized by a loss of some immune function and the development of frequent, eventually fatal, infectious diseases. Although zidovudine (AZT) has prolonged survival in some patients with AIDS, AZT is quite toxic and there is a need for more effective and less toxic drugs. AS-101 is a synthetic organic compound containing the metal tellurium that is being tested because in laboratory studies it improved immune functions.

Patients are given intravenous infusions of AS-101 3 times a week for 12 weeks. The first group of 6 patients receives a dose that did not cause toxic effects in a preliminary study. If no adverse effects occur, the next 6 patients receive a higher dose level and so on, until an optimum dose has been reached. The investigators will determine the optimum dose based on the type and severity of adverse effects experienced by the patients on the study and by the effect of the drug on the immune function of the patient and its effect on the HIV infection. Samples of blood and urine are taken periodically during the study and skin tests are performed 3 times to aid in the evaluation of AS-101. Patients receive standard treatment for any infections that develop during the study.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Ketoconazole.
  • Standard outpatient therapy for infections developing during the trial.
  • Oral acyclovir for up to 7 days.

Patients must have:

  • Antibody to HIV by ELISA.
  • AIDS or AIDS related complex (ARC).
  • T4 cell count < 400 cells/mm3 on 2 determinations at least 72 hours apart.

Prior Medication:

Allowed:

  • Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Ketoconazole.
  • Oral acyclovir for up to 7 days.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Active opportunistic infection or malignancy requiring concurrent treatment.
  • Serious medical problems, such as diabetes, renal disease, ASHD, or hypertension, which would complicate interpretation of treatment results.
  • Transfusion requirements exceeding 2 transfusions per month in order to achieve hemoglobin > 9 g/dl.

Concurrent Medication:

Excluded:

  • Treatment for active opportunistic infection or malignancy.
  • Systemic antiviral preparations.
  • Immunosuppressive agents.
  • Immunostimulation therapy.
  • Specific therapy for Kaposi's sarcoma or other malignancies.

Concurrent Treatment:

Excluded:

  • More than 2 units of red blood cell transfusions per month in order to achieve hemoglobin > 8 g/dl.

Patients unlikely or unable, for reasons such as distance from the hospital or psychological considerations, to comply with the requirements of the protocol, especially in regard to regular attendance for treatment, are excluded.

Prior Medication:

Excluded:

  • Systemic antiviral preparations.
  • Isoprinosine.
  • Excluded with 1 month of study entry:
  • Immunosuppressive agents.
  • Immunomodulators.

Prior Treatment:

Excluded:

  • Immunostimulation therapy, such as BCG vaccine.

Active drug or alcohol abuse.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001006

Locations
United States, New York
Mount Sinai Med Ctr
New York, New York, United States, 10029
Sponsors and Collaborators
Investigators
Study Chair: Sacks HS
Study Chair: Hassett J
  More Information

Publications:
Lewi DS, Acceturi CA, Diaz RS, Lofty C, Sader H. AS 101: tolerability, safety and clinical efficacy in HIV positive patients with advanced disease. Int Conf AIDS. 1992 Jul 19-24;8(3):100 (abstract no PuB 7310)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001006     History of Changes
Other Study ID Numbers: ACTG 046, 11020
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Infusions, Intravenous
Immunologic Surveillance
Drug Evaluation
Adjuvants, Immunologic
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
ammonium trichloro(dioxoethylene-O,O'-)tellurute

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
AIDS-Related Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Adjuvants, Immunologic
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 18, 2014