HIV Infections Clinical Trial
Official title:
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
NCT number | NCT00002266 |
Other study ID # | 045B |
Secondary ID | 753A-103-US |
Status | Completed |
Phase | N/A |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Univ of Arizona / Health Science Ctr | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
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