NCT00002013

Brief Summary

To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1990

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related Complexammonium trichloro(dioxoethylene-O,O'-)telluruteZidovudine

Interventions

ZidovudineDRUG
AS-101DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Concurrent Medication:
  • Required:
  • Zidovudine (AZT).
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Allowed ONLY with permission of the Wyeth-Ayerst medical monitor:
  • Standard therapy for infections that develop during the study period.
  • Oral acyclovir.
  • Nystatin.
  • Ketoconazole.
  • Immunomodulators.
  • Specific therapy for malignancies (including Kaposi's sarcoma).
  • Patients must have the following:
  • Diagnosis of AIDS or AIDS related complex (ARC).
  • Provide informed written consent.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active opportunistic infection or malignancy requiring treatment at study entry.
  • Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
  • Evidence of central nervous system (CNS) opportunistic infection or malignancy.
  • Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results.
  • Dementia.
  • Evidence of = or \> 2 + proteinuria at study entry.
  • Concurrent Medication:
  • Excluded without permission of the Wyeth-Ayerst medical monitor:
  • Immunomodulators.
  • Specific therapy for malignancies (including Kaposi's sarcoma).
  • Patients with the following are excluded:
  • Active opportunistic infection or malignancy requiring treatment at study entry.
  • Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County - USC Med Ctr

Los Angeles, California, 900331084, United States

Location

Related Publications (1)

  • Laporate JP, Frottier J, Dormont D, Imbert JC, Albeck M, Najman A. As 101 in association with azt in AIDS patients: a phase I pilot study. Int Conf AIDS. 1989 Jun 4-9;5:405 (abstract no WBP320)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

Zidovudineammonium trichloro(dioxoethylene-O,O'-)tellurate

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1990-12

Locations

US(1)