Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
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.
Enrollment during the first 8 weeks of the study is restricted to hemophiliacs and sexual partners of hemophiliacs with asymptomatic HIV disease. After the initial 8 weeks this restriction is lifted. Patients are randomized to one of four treatment arms with dosing of AZT plus ddI or ddI alone.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Allowed for up to 2 weeks:
Allowed but preferably not on a continuous basis for > 72 hours:
Patients must be:
Allowed:
NOTE:
Prior Medication:
Allowed:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with a history of any of the following are excluded:
Prior Medication:
Excluded within 4 weeks of study entry:
Excluded:
Prior Treatment:
Excluded within 3 months of entry:
History of recent alcohol abuse.
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal