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 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT00002357
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Treatment for opportunistic infection that develops on study.
Recommended:
* PCP prophylaxis if CD4 count falls below 200 cells/mm3.
Patients must have:
* HIV infection.
* CD4 count 200 - 500 cells/mm3.
* HIV-1 RNA PCR value of 10000 copies/ml or higher.
* Asymptomatic or mildly symptomatic disease.
* No past or current AIDS-defining event.
* Consent of parent or guardian if less than legal age of consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Endocrine, hepatic, renal, or gastrointestinal disease.
* Cardiovascular conduction disease.
* Concomitant medical illness that may complicate study conduct or interpretation of results.
* Other factors that may interfere with patient compliance.
Concurrent Medication:
Excluded:
* Antiretroviral agents other than study drugs.
* Oral contraceptives.
* Cytotoxic chemotherapy.
* Immunomodulators.
* Antiproliferative agents.
* Corticosteroids.
* Anabolic steroids.
* Estrogens.
* Quinoxaline derivatives.
Concurrent Treatment:
Excluded:
* Radiation therapy.
Patients with the following prior conditions are excluded:
* History of hypersensitivity to quinoxaline derivatives or intolerance to AZT.
* History of cardiovascular conduction disease.
* Prior participation in this study or any study using HBY 097.
* Recent use of a drug that interferes with drug metabolism, absorption, distribution, or excretion.
* History of thyroid disease.
Prior Medication:
Excluded at any time:
Prior non-nucleoside reverse transcriptase inhibitors.
Excluded within 30 days prior to study entry:
* Any antiretroviral therapy.
* Oral contraceptives.
* Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons.
* Cytotoxic chemotherapeutic agents.
* Other investigational drugs.
Excluded within 6 months prior to study entry:
Immunotherapeutic vaccine.
Prior Treatment:
Excluded within 30 days prior to study entry:
* Radiation therapy.
* An experimental device. Current ethanol or illicit drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002357
Study Brief:
Protocol Section:
NCT00002357