Completed
A Phase One Study of AS-101 in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-01
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of AS-101 in Patients With AIDS or AIDS Related Complex (ARC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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