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

NCT ID: NCT00001006

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1993-03-31

Brief Summary

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.

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.

Conditions

HIV Infections

Keywords

Infusions, Intravenous; Immunologic Surveillance; Drug Evaluation; Adjuvants, Immunologic; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; ammonium trichloro(dioxoethylene-O,O'-)tellurute

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

AS-101

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sacks HS

Role: STUDY_CHAIR

Hassett J

Role: STUDY_CHAIR

Locations

Mount Sinai Med Ctr

New York, New York, United States

Countries

United States

References

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)

Reference Type: BACKGROUND

Other Identifiers

11020

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 046

Identifier Type: -

Identifier Source: org_study_id