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)
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
March 1, 1993
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Med Ctr
New York, New York, 10029, United States
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sacks HS
- STUDY CHAIR
Hassett J
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
March 1, 1993
Last Updated
November 1, 2021
Record last verified: 2021-10