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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00002333
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* G-CSF and erythropoietin.
* Prophylaxis or chronic suppression/maintenance therapy with dapsone, aerosolized pentamidine, isoniazid, rifampin, fluoroquinolones, pyrazinamide, ethambutol, fluconazole, itraconazole, acyclovir, clotrimazole, nystatin, trimethoprim/sulfamethoxazole, pyrimethamine, folic acid, sulfadiazine, clindamycin, and fansidar.
Concurrent Treatment:
Allowed:
* Limited localized radiation therapy to the skin.
Patients must have:
* Documented HIV infection.
* CD4 count 50 - 300 cells/mm3.
* Received prior AZT that has been discontinued at least 28 days prior to study entry.
* No active opportunistic infection requiring immediate treatment.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Signs or symptoms of peripheral neuropathy.
* Malabsorption or inadequate oral intake (defined as unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort.
* Malignancy, visceral Kaposi's sarcoma, or lymphoma requiring systemic chemotherapy and/or radiotherapy within the next 48 weeks.
* Any grade 3 or worse laboratory or clinical abnormality.
* Inability to comply with protocol requirements.
Concurrent Medication:
Excluded:
* Other antiretroviral drugs.
* Experimental drugs.
* Nephrotoxic or hepatotoxic drugs.
* Drugs likely to cause peripheral neuropathy.
* Antineoplastic agents.
* Biologic response modifiers.
Concurrent Treatment:
Excluded:
* Radiation therapy other than limited localized therapy to skin.
Patients with the following prior conditions are excluded:
* History of non-Hodgkin's lymphoma.
* Unexplained fever \>= 38.5 C (101.5 F) persisting for 14 days or longer within the 28 days prior to study entry.
* Unexplained, chronic diarrhea (defined as 3 or more loose stools daily) persisting for 14 days or longer within the 28 days prior to study entry.
* History of grade 2 or worse peripheral neuropathy.
Prior Medication:
Excluded:
* Prior HIV proteinase inhibitor.
* Prior antiretroviral therapy other than AZT.
* Acute therapy for opportunistic infection within 14 days prior to study entry.
Prior Treatment:
Excluded:
* More than 3 units of blood in any 21-day period within 3 months prior to study entry.
Required:
* Prior AZT.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002333
Study Brief:
Protocol Section:
NCT00002333