A Phase I/II, Open Label Study to Evaluate the Antiviral Potential of Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine) in Patients With Asymptomatic HIV Disease

Inclusion Criteria Concurrent Medication: Allowed: Aerosolized pentamidine. Acute and intermittent therapy with mycostatin and mycelex. Isoniazid, if no alternative therapy is available. Allowed for up to 2 weeks: Acyclovir for Herpes infection (withhold didanosine during therapy). Acute therapy with fluconazole or ketoconazole. Allowed but preferably not on a continuous basis for > 72 hours: Acetaminophen. Ibuprofen. Nonsteroidal antiinflammatory agents. Patients must be: HIV antibody positive. Asymptomatic or have persistent generalized lymphadenopathy. Diagnosed with one of the listed coagulopathies. OR Sexual partner of someone with the above criteria. Allowed: Basal cell carcinoma or in situ carcinoma of the cervix. NOTE: As of January, 1991 full accrual of patients with prior AZT use has been reached - NOW ACCRUING ONLY THOSE WITH NO PRIOR AZT USE. Hemophilia restriction has been lifted. Prior Medication: Allowed: Zidovudine (AZT) for a total of = or < 13 months. NOTE: As of January, 1991 accrual of these patients was reached, NOW ONLY PATIENTS WITH NO PRIOR AZT. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Unexplained temperature > 38 degrees C for more than 5 consecutive days or on more than 10 days in any 30-day period in the 2 years prior to study entry. Unexplained diarrhea defined as at least 3 liquid stools/day persisting more than 7 days within 2 years prior to study entry. Unintentional weight loss of > 10 pounds or > 10 percent of usual body weight within 2 years prior to study entry. Oral hairy leukoplakia at any time prior to study entry. Recurrent oral candidiasis unrelated to the use of antibiotics within 2 years prior to entry or unrelated to the use of antibiotics within the past 3 months. Herpes zoster within 2 years prior to study entry. Seizures within the past 6 months or currently requiring anticonvulsants for control. Current heart disease. Current psychological or emotional problems sufficient in the investigator's opinion to prevent adequate compliance with study therapy. Gout. Concurrent Medication: Excluded: Rifampin. Chemoprophylaxis for Pneumocystis carinii pneumonia other than aerosolized pentamidine. Intravenous pentamidine. Other antiretroviral agents, experimental medication, biological response modifiers, systemic corticosteroids, cimetidine, and ranitidine. Barbiturates. Oral acidifying agents. Patients with a history of any of the following are excluded: AIDS-defining opportunistic infection, advanced AIDS-related complex, or malignancy. Acute or chronic pancreatitis. Grade 2 or higher neuropathy based on the Neuropathy Targeted Symptom Questionnaire. Seizures. Zidovudine therapy for = or > 13 months. Heart disease. Psychological or emotional problems sufficient in the investigator's opinion to prevent adequate compliance with study therapy. Gout. Prior Medication: Excluded within 4 weeks of study entry: Antiretroviral agents, including ribavirin, HPA-23, rifampin, AL721. Excluded within 3 months of study entry: Significant course of immunomodulating agents, such as steroids (> 1 week), isoprinosine, thymic factors, or any other experimental drugs. Excluded within 30 days prior to study entry: Neurotoxic drugs. Excluded: Didanosine (ddI). Dideoxycytidine (ddC). Zidovudine (AZT) if received for > 13 months. Prior Treatment: Excluded within 3 months of entry: Other experimental therapy. History of recent alcohol abuse.