a third-party blinded, placebo controlled comparative study of as-101 administered intravenously in hiv positive patients with advanced disease

Conditions: HIV Infections

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.


Eligibility criteria:
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 \ 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).

Keywords: acquired immunodeficiency syndrome aids-related complex ammonium trichloro(dioxoethylene-o,o'-)tellurute zidovudine