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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT00000661
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Required:
* Stable prescribed dosage of zidovudine (AZT), = or \> 500 mg/day.
Allowed:
* Prophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine.
* Erythropoietin.
Patients must be:
* HIV positive by ELISA and Western blot.
* Currently taking a stable prescribed dosage of 500 mg/day of zidovudine (AZT).
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or \< 600 mg/day.
* Significant underlying medical condition that could impair continuous participation in study.
* Malabsorption syndrome (3 or more loose stools a day for at least 4 weeks associated with an unintentional weight loss of at least 10 percent of body weight).
Concurrent Medication:
Excluded:
* Oral contraceptives.
* Cytotoxic chemotherapy.
* Ganciclovir.
* Flucytosine.
* Probenecid.
* Opiates.
* Valproic acid.
* Sulfa drugs.
* Sucralfate.
* Dapsone.
* Rifampin.
* Antacids within 2 hours of zidovudine (AZT) dose.
* Isoniazid.
* Ketoconazole.
* Pyrimethamine.
* Clindamycin.
* Aspirin.
* Ibuprofen.
* Investigational drugs not specifically allowed.
Patients with the following are excluded:
* Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or \< 600 mg/day.
* Significant underlying medical condition that could impair continuous participation in study.
* Unable to take oral medication reliably.
Prior Medication:
Excluded within 30 days of study entry:
* Antiretroviral agents other than zidovudine (AZT).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00000661
Study Brief:
Protocol Section:
NCT00000661