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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00002094
Eligibility Criteria:
Inclusion Criteria
Patients must have:
* Enrollment on protocol RV-43 (AZT resistance study).
* Development of a primary RV-43 study endpoint-opportunistic infection.
* HIV isolate with an AZT IC50 \> 50 times that of the sensitive type strain.
* Able to swallow tablets without difficulty.
* Normal QTc interval on EKG.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine).
* Severe uncontrollable diarrhea or vomiting or known malabsorption.
* Symptomatic hyperlipidemia.
Concurrent Medication:
Excluded:
* Other experimental drugs.
* AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted).
Patients with the following prior conditions are excluded:
History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction.
Prior Medication:
Excluded:
* Experimental drugs within 4 weeks prior to study entry.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00002094
Study Brief:
Protocol Section:
NCT00002094