A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following are excluded:
• •Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.
• •AIDS-dementia complex = or \> stage 2.
• •Active AIDS defining opportunistic infections not specifically allowed.
• •Intractable diarrhea.
• •Grade 2 neuropathy, based on the Neuropathy Targeted Symptom Questionnaire, or any moderate abnormality indicative of peripheral neuropathy, particularly impaired sensation of sharp pain, light touch, or vibration in the lower extremities, distal extremity weakness, or distal extremity hyperreflexia.
• •Prior history of acute pancreatitis within past 2 years or chronic pancreatitis.
• •History of seizures within past 2 years or currently requiring anticonvulsants for control.
• •History of past or current heart disease.
• •Malignancy likely in the investigator's opinion to require cytotoxic chemotherapy during the expected course of this trial.
• •Life expectancy \< 3 months.
• •Concurrent Medication:
• •Excluded:
• •Isoniazid (INH). Neurotoxic drugs. Oral acidifying agents.
• •Patients with the following are excluded:
• •Psychological or emotional problems sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy.
• •AIDS-dementia complex = or \> stage 2.
• •Active AIDS defining opportunistic infections not specifically allowed.
• •Intractable diarrhea.
• •Prior history of acute pancreatitis within past 2 years or chronic pancreatitis.
• •History of seizures within past 2 years or currently requiring anticonvulsants for control.
• •History of past or current heart disease.
• •Malignancy likely in the investigator's opinion to require cytotoxic chemotherapy during the expected course of this trial.
• •Life expectancy = or \< 3 months.
• •Previous participation in any study of ddI, ddC or d4T.
• •Prior Medication:
• •Excluded:
• •Ganciclovir (DHPG).
• •Excluded within 1 month of study entry:
• •ddI and any other antiretroviral drug or investigational anti-HIV agent except for zidovudine (AZT).
• •Interferons.
• •Immunomodulating drugs.
• •Cytotoxic agents not specifically allowed.
• •Neurotoxic drugs.
• •Excluded within 3 months of study entry:
• •Ribavirin.
• •Prior Treatment:
• •Excluded within 14 days of study randomization:
• •Blood transfusion.
• •Active alcohol or drug abuse that is sufficient, in investigator's opinion, to prevent adequate compliance with study therapy.