HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute
Brief summary
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.
Interventions
DRUGAS-101
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed