An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2

Launched by GLAXO WELLCOME · Aug 30, 2001

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Eligibility criteria

• • Inclusion Criteria
• • Patients must have HIV reactivity.
• * Patients must belong to one of the following three groups according to the CDC classification:
• • IIB - including only those patients with autoimmune thrombocytopenia (platelet count = or \< 100000 platelets/mm3).
• • OR Lymphopenia (lymphocyte count = or \< 1000 cells/mm3).
• • OR Helper cell lymphopenia (helper cells \< the mean of normals).
• • OR CDC classification III or IV-C2.
• • Patients with = or \< involuntary 10 percent weight loss in the last 6 months.
• • ECOG performance status 0 or 1.
• • Weigh 70 kg + or - 15 kg in order to standardize the g/kg dosing.
• • Positive antibody for HIV by an ELISA test kit. If the ELISA is negative, then eligibility will be confirmed by second confirmatory test, i.e., immunoblot.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following are excluded:
• • AIDS or the CDC classification stage IV except stage IV-C2.
• • HIV antibody negative by immunoblot.
• • Persistent fevers of \> 38.5 degrees C.
• • Persistent diarrhea undiagnosed \> 1 month.
• • Involuntary weight loss of \> 10 percent in the 6 months prior to study entry.
• • ECOG performance status of 2, 3, or 4.
• * Class IV-C2 with prior history of:
• • Multidermal herpes zoster.
• • Oral candidiasis on more than one occasion.
• • Tuberculosis.
• Concurrent Medication:
• Excluded:
• • Other antiretroviral agents.
• • Active immunomodulating agents.
• • Any other experimental therapy.
• • Drugs which cause anemia or neutropenia.
• • Drugs which are glucuronidated and may interfere with the metabolism of AZT, i.e., acetaminophen \> 5 days.
• • Acyclovir systemically administered \> 5 days.
• • Any other experimental agents.
• Patients with the following are excluded:
• • AIDS or the CDC classification stage IV except stage IV-C2.
• • HIV antibody negative by immunoblot.
• • Persistent fevers of \> 38.5 degrees C.
• • Persistent diarrhea undiagnosed \> 1 month.
• • Involuntary weight loss of \> 10 percent in the 6 months prior to study entry.
• • ECOG performance status of 2, 3, or 4.
• * Class IV-C2 with prior history of:
• • Multidermal herpes zoster.
• • Oral candidiasis on more than one occasion.
• • Tuberculosis.
• Prior Medication:
• Excluded within 3 months of study entry:
• • Other antiretroviral agents. Active immunomodulating agents.
• * Excluded within 2 weeks of study entry:
• • Drugs which cause anemia or neutropenia.
• • Drugs which are glucuronidated and may interfere with the metabolism of zidovudine (AZT), i.e., acetaminophen \> 5 days.
• • Acyclovir systemically administered \> 5 days.
• • Any other experimental agents.
• • Known active drug abuse.