Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT00000969
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Acyclovir (if patient is also receiving ddC, clinical monitoring should be more frequent).
* Analgesics, antiemetics, antidiarrheal agents, or other necessary treatment for symptomatic therapy.
* Interferons for maintenance therapy of Kaposi's sarcoma.
* GM-CSF.
Required:
* Prophylaxis against Pneumocystis carinii pneumonia (PCP) if their absolute CD4+ lymphocyte count is \< 200 cells/mm3 at study entry. PCP prophylaxis for patient with CD4+ counts between 200 and 300 cells/mm3 is at discretion of patient's primary physician.
* NOTE: There is potential interaction of ddI and dapsone.
Concurrent Treatment:
Allowed:
* Transfusion, erythropoietin.
Patients must have the following:
* Zidovudine (AZT) failure after having received a cumulative duration of at least 6 months.
* AZT intolerance - rechallenge is not required for patients exhibiting = or \> grade III cutaneous symptoms.
* Diagnosis of AIDS or CD4+ = or \< 300 cells/mm3 OR AIDS-defining illness other than Kaposi's sarcoma.
* Willingness and ability to comply with protocol.
* Informed consent must be obtained for all study participants in accordance with state law, local IRB requirements, and 45 CFR Part 46. AMENDED 11/19/90 to include assent by minors if they are physically able, in addition to consent by parents.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Any disorders for which the study drugs are contraindicated (didanosine (ddI)) is contraindicated in renal impairment, heart disease, receiving renal dialysis.
* Active opportunistic infection.
Concurrent Medication:
Excluded:
* Other antiretroviral agents.
* Use of drugs associated with peripheral neuropathy or use of agents that may cause pancreatitis including intravenous pentamidine and alcohol should be restricted or avoided.
Concurrent Treatment:
Excluded:
* Other concurrent antiretroviral clinical trials.
Patients with the following are excluded:
* History of pancreatitis, peripheral neuropathy, uncontrolled seizures, renal impairment, heart disease, stage 2 or higher ADC.
* Any other disorders for which the study drugs are contraindicated, i.e., ddI is contraindicated in renal impairment, patients receiving renal dialysis, and heart disease.
* Receiving acute therapy for active AIDS defining opportunistic infection on enrollment.
Prior Medication:
Excluded:
* Didanosine (ddI).
* Dideoxycytidine (ddC) .
Excessive alcohol use that, in investigator's opinion, puts patient at risk of developing pancreatic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00000969
Study Brief:
Protocol Section:
NCT00000969