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

Last updated on May 12, 2018

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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An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
To 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.
Not Provided
Interventional
Not Provided
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: AS-101
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002266
045B
753A-103-US
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
December 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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