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

• Status: Completed
• Trial end date: 1993-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ammonium trichloro(dioxoethylene-O,O'-)tellurate

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.