Treatment of AIDS and AIDS Related Complex. Part-1- Treatment of Patients With ARC (AZT Vs. Placebo)

Launched by GLAXO WELLCOME · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Patient must have AIDS related complex (ARC) as defined by Walter Reed stages, be ambulatory, and be able to give informed consent.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with unstable disease characterized by the following are excluded:
• • Hospitalization within the past 14 days.
• • Major opportunistic infection, current or past.
• * An active infection of onset during the past 30 days, as evidenced by symptoms, signs, or laboratory abnormalities such as:
• • Temperature = or \> 100.5 degrees F.
• • Night sweats.
• • Weight loss = or \> 10 percent of body weight.
• • Diarrhea (3 or more bowel movements/day).
• • Persistent cough, shortness of breath, or dyspnea on exercise.
• • Abnormal chest x-ray suggesting pneumonia or increased arterial-alveolar (A-a) gradient.
• • Altered mental status, seizures, or focal neurologic signs.
• • Abnormal computerized tomography (CT) scan or magnetic resonance imaging (MRI) suggestive of toxoplasmosis, peripheral mononuclear leukocytes, lymphoma, or other focal abnormality of the central nervous system (CNS).
• • Abnormal cerebrospinal fluid (CSF) suggestive of cryptococcal, mycobacterial, or other meningitis. (The decision to perform invasive tests, such as lumbar puncture, specialized microbiological tests such as bone marrow culture for Mycobacteria or Histoplasma capsulatum, or specialized radiological tests such as CT scan or MRI should be based on clinical assessment of the patient.)
• • Kaposi's sarcoma.
• • Lymphoma; malignancy requiring chemotherapy.
• • Dementia.
• • Requiring hemodialysis or renal insufficiency or failure.
• • Leukopenia.
• • Thrombocytopenia.
• Patients with the following are excluded:
• • Unstable disease.
• • Kaposi's sarcoma.
• • Lymphoma; malignancy requiring chemotherapy.
• • Dementia.
• • Major opportunistic infection, current or past.
• • Anemia (hemoglobin less than 9.5 g/dl).
• Prior Medication:
• Excluded within 1 month of study entry:
• • Ribavirin or zidovudine (AZT) or other antivirals.
• • Immunomodulating agents.