ABOUT THIS STUDY
- 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.
- 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.
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
- 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).
- 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.
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).
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