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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT00000806
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Required for patients with CD4 count \<= 200 cells/mm3:
* PCP prophylaxis using TMP/SMX or aerosolized pentamidine.
Allowed:
* Topical antifungal agents.
* Up to 1000 mg/day acyclovir as maintenance therapy for herpes simplex virus.
* Antibiotics for bacterial infections.
* Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone for symptomatic treatment.
Patients must have:
* HIV infection.
* CD4 count 150 - 500 cells/mm3.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Unable to tolerate the standard diet required for the study.
* Unable to give informed consent.
Concurrent Medication:
Excluded:
* Antiretrovirals and biologic response modifiers (including HIV vaccines).
* Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.
* Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.
* Allopurinol.
* Omeprazole.
* Astemizole.
* Terfenadine.
* Loratadine.
* Psychotropics.
* Phenylbutazone.
* Barbiturates.
* Benzodiazepines.
* Monoamine oxidase inhibitors.
* H-2 blockers.
* Anticonvulsants.
* Coumadin anticoagulants.
* Oral contraceptives.
* Antiarrhythmics.
* Diltiazem.
* Metronidazole.
* Erythromycin.
* Chloramphenicol.
* Fluoroquinolones.
* Disulfiram.
* Erythropoietin.
* G-CSF or GM-CSF.
* Systemic corticosteroids.
* Alcohol, including alcohol-containing medications.
Patients with the following prior conditions are excluded:
* Unexplained temperature \>= 38.5 C for any 7 days within the 30 days prior to study entry.
* Chronic diarrhea (\>= three stools per day) for any 15 days within the 30 days prior to study entry.
* Malignancy other than basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, and minimal Kaposi's sarcoma.
Prior Medication:
Excluded at any time:
* Prior HIV protease inhibitor.
Excluded within 30 days prior to study entry:
* Investigational drugs.
* Recombinant erythropoietin.
* G-CSF or GM-CSF.
* Interferon or interleukin.
* Any HIV-1 vaccine.
Excluded within 14 days prior to study entry:
* Antiretrovirals.
* Acute therapy for any opportunistic or other serious infection.
* Therapy for malignancy.
* Maintenance with ketoconazole, fluconazole, itraconazole, ganciclovir, foscarnet, pyrimethamine, sulfadiazine, clindamycin, azithromycin, isoniazid, rifampin, rifabutin, ethambutol, pyrazinamide, clofazimine, or clarithromycin.
* Prophylaxis for Mycobacterial infection or fungal infections other than Candidiasis.
Excluded within 7 days prior to study entry:
* Allopurinol.
* Omeprazole.
* Astemizole.
* Terfenadine.
* Loratadine.
* Psychotropics.
* Phenylbutazone.
* Barbiturates.
* Benzodiazepines.
* Monoamine oxidase inhibitors.
* H-2 blockers.
* Anticonvulsants.
* Coumadin anticoagulants.
* Oral contraceptives.
* Antiarrhythmics.
* Diltiazem.
* Metronidazole.
* Erythromycin.
* Chloramphenicol.
* Fluoroquinolones.
* Disulfiram.
Risk Behavior: Excluded:
* History of substance or alcohol abuse.
* Ingestion of more than 50 g alcohol daily within 6 months prior to study entry.
* Recovered alcoholic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00000806
Study Brief:
Protocol Section:
NCT00000806