HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, ammonium trichloro(dioxoethylene-O,O'-)tellurute, Zidovudine
Brief summary
To compare the effect of AS-101 to that of placebo on clinical efficacy and immunologic function in HIV positive patients with advanced disease. To compare the effect of AS-101 to that of placebo on occurrence of disease progression in HIV positive patients with advanced disease as defined by: (1) development of new diagnostically confirmed major opportunistic infection(s); or (2) development of AIDS-related dementia. To compare the effect of zidovudine (AZT) plus AS-101 versus AZT alone (placebo arm) on clinical efficacy and immunologic function in patients who require anti-viral therapy due to disease progression. Garlic capsules will be given to all study participants to mask the obvious garlic odor of AS-101.
Interventions
DRUGZidovudine
DRUGAS-101
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Concurrent Medication: Allowed: * Standard therapy including acyclovir or ganciclovir for infections that develop during the study period. (Prophylactic acyclovir is not permitted.) Standard therapy for persistent infections may continue. * Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor. * Zidovudine (AZT) may be added only if there is disease progression and after the patient has been in the study for a minimum of eight weeks. * Garlic capsules will be given to all study participants to mask side effects of AS-101. * Required: * Accepted standard prophylaxis for patients with prior Pneumocystis carinii pneumonia (PCP). Patients must have the following: * Diagnosis of AIDS or AIDS-related complex (ARC). * Life expectancy \> 6 months. * Provide written informed consent.
Exclusion criteria
Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Evidence of severe liver dysfunction (serum albumin \< 2.5 g/dl, prothrombin time \> 15 seconds or SGOT or SGPT \> 3 x upper limits of normal), gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorders which would prevent compliance with the protocol. * Evidence of AIDS related dementia. * Presence of disseminated Kaposi's sarcoma defined as any visceral lesions or \> 20 cutaneous lesions; or Kaposi's sarcoma without at least one other AIDS defining characteristic. * Presence of any lymphoma. * Active opportunistic infection currently requiring treatment unless the infection has stabilized and continuing treatment is only required to prevent relapse (e.g., CNS toxoplasmosis or resolving tuberculosis). Concurrent Medication: Excluded: * Prophylactic acyclovir. * Immunomodulators or specific therapy for malignancies (including Kaposi's sarcoma) allowed only with permission of Wyeth-Ayerst medical monitor. * Zidovudine (AZT) may be added only if there is disease progression and after the patient has been in the study for a minimum of eight weeks. Patients with the following are excluded: * Evidence of severe organ dysfunction as defined in Exclusion complications or other specified disease conditions. * Unlikely or unable to comply with the requirements of the protocol. Prior Medication: Excluded within 8 weeks of study entry: * Any immune stimulation agents such as BCG vaccine, interferons, or other immune modulators within 8 weeks. * Any immunosuppressive agent within 8 weeks. * Excluded within 12 weeks of study entry: * Zidovudine (AZT).
Countries
Brazil
Outcome results
None listed