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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001006
First Posted: August 31, 2001
Last Update Posted: March 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
November 2, 1999
August 31, 2001
March 29, 2012
Not Provided
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Complete list of historical versions of study NCT00001006 on ClinicalTrials.gov Archive Site
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A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)
A Phase One Study of AS-101 in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
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.

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.

Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: AS-101
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 1993
Not Provided

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.

Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00001006
ACTG 046
11020 ( Registry Identifier: DAIDS ES Registry Number )
Not Provided
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Sacks HS
Study Chair: Hassett J
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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