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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To assess the safety and to evaluate the anti-HIV effect of low-, moderate-, and high-dose schedules of zidovudine (AZT) plus didanosine (ddI) versus ddI alone in asymptomatic HIV-infected patients. Because of the failure with long-term (more than 1 year) use of, frequency of toxicity from, and drug resistance to AZT, drug combinations need to be developed to enable lower, less toxic doses of AZT to be used and to slow or prevent the development of resistance, while providing at least the same effectiveness.

Key facts

Study ID

NCT00000656

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

116

Expected to finish

1993-11-01

Last updated by the study team

2021-11-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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.

Where it is running

• Palo Alto Veterans Adm Med Ctr / Stanford Univ — Palo Alto, California, United States
• Whitman - Walker Clinic — Washington D.C., District of Columbia, United States
• Univ of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Univ of Pittsburgh Med School — Pittsburgh, Pennsylvania, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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