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An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Concurrent Medication:

Allowed:

- Standard therapy for infections.

- Acyclovir.

- Ganciclovir.

- Allowed only with permission of Wyeth-Ayerst medical monitor:

- Zidovudine (AZT).

- Immunomodulators.

- Specific therapy for malignancies (including Kaposi's sarcoma).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Evidence of severe liver dysfunction (serum albumin 5 x upper
limit of normal, prothrombin time > 15 seconds), or gastrointestinal, renal,
respiratory, endocrine, hematologic, cardiovascular system abnormalities or
psychiatric disorder other than abnormalities secondary to AIDS or AIDS related
complex (ARC).

- Evidence of AIDS-related central nervous system involvement.

- Disseminated Kaposi's sarcoma.

Concurrent Medication:

Excluded without permission of Wyeth-Ayerst medical monitor:

- Zidovudine (AZT).

- Immunomodulators.

- Specific therapy for malignancies (including Kaposi's sarcoma).

Patients with the following are excluded:

- Evidence of major system abnormalities other than abnormalities secondary to AIDS or
AIDS related complex.

- Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.

- Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 4 weeks of study entry:

- Systemic antiviral agents.

- Immunosuppressive agents.

- Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.

Patients must:

- Have a diagnosis of AIDS or AIDS related complex (ARC).

- Demonstrate intolerance or refusal to take zidovudine (AZT).

- Provide written informed consent.

NCT00002266
Pfizer
Completed
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients

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Descriptive Information
Brief Title  ICMJE An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
Official Title  ICMJE An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
Brief SummaryTo compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE Drug: AS-101
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Standard therapy for infections.
  • Acyclovir.
  • Ganciclovir.
  • Allowed only with permission of Wyeth-Ayerst medical monitor:
  • Zidovudine (AZT).
  • Immunomodulators.
  • Specific therapy for malignancies (including Kaposi's sarcoma).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Evidence of severe liver dysfunction (serum albumin < 3 g/dl, SGOT or SGPT > 5 x upper limit of normal, prothrombin time > 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).
  • Evidence of AIDS-related central nervous system involvement.
  • Disseminated Kaposi's sarcoma.

Concurrent Medication:

Excluded without permission of Wyeth-Ayerst medical monitor:

  • Zidovudine (AZT).
  • Immunomodulators.
  • Specific therapy for malignancies (including Kaposi's sarcoma).

Patients with the following are excluded:

  • Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex.
  • Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.
  • Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Systemic antiviral agents.
  • Immunosuppressive agents.
  • Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.

Patients must:

  • Have a diagnosis of AIDS or AIDS related complex (ARC).
  • Demonstrate intolerance or refusal to take zidovudine (AZT).
  • Provide written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002266
Other Study ID Numbers  ICMJE 045B
753A-103-US
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountNIH AIDS Clinical Trials Information Service
Verification DateDecember 1990

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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