The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

In one human study, patients with AIDS or advanced ARC who received AZT had fewer life-threatening infections, improved in weight and performance, and lived longer than patients who received a placebo (inactive medication). Further studies are needed because toxic effects associated with the use of AZT were noted and the long-term effectiveness and toxicity of AZT are still unknown. It is also unknown if AZT will benefit patients with less severe HIV infections such as early ARC or PGL.

Patients accepted into the study are randomly assigned to receive either AZT or placebo. Treatment conti...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit.
• • The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be \< 800 cells/mm3, and at least 1 of 2 counts and the mean must be \> 200 cells/mm3). The last count must be within 14 days of study entry.
• Concurrent Medication:
• Allowed:
• • Acetaminophen and acetaminophen products but use should be minimized. Continuous use for \> 72 hours is discouraged.
• • Aerosolized pentamidine.
• Prior Medication:
• Allowed:
• • Chemoprophylaxis for Pneumocystis carinii pneumonia with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer if patient has CD4(+) count \< 200 cells/mm3 measured on 2 determinations at least 48 hours apart.
• • Exclusion Criteria
• Concurrent Medication:
• Excluded:
• • Other antiretroviral agents, biologic modifiers or corticosteroids.
• • Other experimental medications.
• • Systemic chemoprophylaxis of Pneumocystic carinii pneumonia (PCP) - aerosolized pentamidine is allowed.
• Prior Medication:
• Excluded:
• • Zidovudine (AZT).
• • Other antiretroviral agents.
• * Excluded within 30 days of study entry:
• • Biologic modifiers or corticosteroids.
• * Excluded within 60 days of study entry:
• • Ribavirin.
• Prior Treatment:
• Excluded within 30 days of study entry:
• • Blood transfusions.
• Patients may not have any of the following diseases or symptoms:
• • Active oral candidiasis at entry.
• • An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
• • Temperature \> 38.5 degrees C persisting for \> 14 consecutive days or \> 15 days in a 30-day interval present at entry.
• • Chronic diarrhea defined as = or \> 3 liquid stools per day, persisting for \> 14 days without a definable cause during the past 2 years.
• • HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
• • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
• • Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.
• Patients may not have any of the following diseases or symptoms:
• • Active oral candidiasis at entry.
• • An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
• • Temperature \> 38.5 degrees C persisting for \> 14 consecutive days or \> 15 days in a 30-day interval present at entry.
• • Chronic diarrhea defined as = or \> 3 liquid stools per day, persisting for \> 14 days without a definable cause during the past 2 years.
• • HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
• • Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
• • Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.
• • Active drug or alcohol abuse.

Trial Officials