Status:
COMPLETED
A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 ...
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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1993
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00001006
End Date
March 1 1993
Last Update
November 1 2021
Active Locations (1)
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1
Mount Sinai Med Ctr
New York, New York, United States, 10029